Trial Outcomes & Findings for Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (NCT NCT03933618)

Results Overview

15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

At baseline

Results posted on

2019-11-18

Participant Flow

Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.

Participant milestones

Participant milestones
Measure	Anastrazole-clomiphene-placebo anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Baseline STARTED	4	4	4	4	4	4
Baseline COMPLETED	4	4	4	4	4	4
Baseline NOT COMPLETED	0	0	0	0	0	0
Baseline to Week 8 STARTED	4	4	4	4	4	4
Baseline to Week 8 COMPLETED	4	4	4	4	4	4
Baseline to Week 8 NOT COMPLETED	0	0	0	0	0	0
Week 8 to Week 16 STARTED	4	4	4	4	4	4
Week 8 to Week 16 COMPLETED	4	4	4	4	4	4
Week 8 to Week 16 NOT COMPLETED	0	0	0	0	0	0
Week 16 to Week 24 STARTED	4	4	4	4	4	4
Week 16 to Week 24 COMPLETED	4	4	4	4	4	4
Week 16 to Week 24 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	24 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	24 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	23 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	4 participants n=10 Participants	4 participants n=115 Participants

PRIMARY outcome

Timeframe: At baseline

Population: Total IIEF reported at the initial encounter.

15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
IIEF (International Index of Erectile Function) Score - Screen Patients 1-6	34 score on a scale	43 score on a scale	57 score on a scale	41 score on a scale	57 score on a scale	24 score on a scale
IIEF (International Index of Erectile Function) Score - Screen Patients 7-12	57 score on a scale	57 score on a scale	45 score on a scale	32 score on a scale	36 score on a scale	55 score on a scale
IIEF (International Index of Erectile Function) Score - Screen Patients 13-18	55 score on a scale	46 score on a scale	41 score on a scale	45 score on a scale	58 score on a scale	32 score on a scale
IIEF (International Index of Erectile Function) Score - Screen Patients 19-24	50 score on a scale	52 score on a scale	55 score on a scale	47 score on a scale	18 score on a scale	62 score on a scale

PRIMARY outcome

Timeframe: Week 8

Population: Total IIEF reported at the end of the first 8 week period

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
IIEF (International Index of Erectile Function) Score - Week 8 Patients 13-18	55 score on a scale	59 score on a scale	32 score on a scale	65 score on a scale	43 score on a scale	28 score on a scale
IIEF (International Index of Erectile Function) Score - Week 8 Patients 19-24	63 score on a scale	65 score on a scale	70 score on a scale	45 score on a scale	25 score on a scale	53 score on a scale
IIEF (International Index of Erectile Function) Score - Week 8 Patients 1-6	25 score on a scale	55 score on a scale	32 score on a scale	20 score on a scale	66 score on a scale	35 score on a scale
IIEF (International Index of Erectile Function) Score - Week 8 Patients 7-12	45 score on a scale	51 score on a scale	63 score on a scale	45 score on a scale	72 score on a scale	37 score on a scale

PRIMARY outcome

Timeframe: Week 16

Population: Total IIEF reported at the end of the second 8 week period - at week 16 Data for patient 23 was not collected in the placebo-clomiphene-anastrazole arm.

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
IIEF (International Index of Erectile Function) Score - Week 16 Patients 1-6	45 score on a scale	53 score on a scale	35 score on a scale	45 score on a scale	66 score on a scale	37 score on a scale
IIEF (International Index of Erectile Function) Score - Week 16 Patients 7-12	43 score on a scale	56 score on a scale	50 score on a scale	55 score on a scale	33 score on a scale	38 score on a scale
IIEF (International Index of Erectile Function) Score - Week 16 Patients 13-18	53 score on a scale	62 score on a scale	37 score on a scale	58 score on a scale	59 score on a scale	15 score on a scale
IIEF (International Index of Erectile Function) Score - Week 16 Patients 19-24	62 score on a scale	38 score on a scale	51 score on a scale	47 score on a scale	—	18 score on a scale

PRIMARY outcome

Timeframe: Week 24

Population: Total IIEF reported at the end of the final 8 week period - at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
IIEF (International Index of Erectile Function) Score - Week 24 Patients 1-6	12 score on a scale	70 score on a scale	42 score on a scale	52 score on a scale	65 score on a scale	41 score on a scale
IIEF (International Index of Erectile Function) Score - Week 24 Patients 7-12	54 score on a scale	60 score on a scale	43 score on a scale	35 score on a scale	27 score on a scale	45 score on a scale
IIEF (International Index of Erectile Function) Score - Week 24 Patients 13-18	60 score on a scale	65 score on a scale	—	72 score on a scale	45 score on a scale	17 score on a scale
IIEF (International Index of Erectile Function) Score - Week 24 Patients 19-24	52 score on a scale	59 score on a scale	60 score on a scale	47 score on a scale	—	14 score on a scale

SECONDARY outcome

Timeframe: Baseline

Population: Normalized Testosterone measured week 0 - initial screen Data not collected for patient 23 in placebo-clomiphene-anastrazole arm

Normalized at \>350ng/dl

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Normalized Testosterone - Screen Patients 1-6	205 ng/dl	330 ng/dl	226 ng/dl	367 ng/dl	315 ng/dl	321 ng/dl
Normalized Testosterone - Screen Patients 7-12	293 ng/dl	237 ng/dl	194 ng/dl	300 ng/dl	214 ng/dl	243 ng/dl
Normalized Testosterone - Screen Patients 13-18	347 ng/dl	328 ng/dl	268 ng/dl	206 ng/dl	321 ng/dl	148 ng/dl
Normalized Testosterone - Screen Patients 19-24	95 ng/dl	291 ng/dl	306 ng/dl	244 ng/dl	—	289 ng/dl

SECONDARY outcome

Timeframe: Week 8

Population: Normalized Testosterone measured at the end of the first 8 week period Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm

Normalized at \>350ng/dl

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Normalized Testosterone - Week 8 Patients 1-6	484 ng/dl	757 ng/dl	566 ng/dl	1316 ng/dl	133 ng/dl	470 ng/dl
Normalized Testosterone - Week 8 Patients 7-12	387 ng/dl	296 ng/dl	693 ng/dl	917 ng/dl	271 ng/dl	298 ng/dl
Normalized Testosterone - Week 8 Patients 13-18	607 ng/dl	453 ng/dl	216 ng/dl	527 ng/dl	270 ng/dl	139 ng/dl
Normalized Testosterone - Week 8 Patients 19-24	545 ng/dl	676 ng/dl	592 ng/dl	497 ng/dl	—	296 ng/dl

SECONDARY outcome

Timeframe: Week 16

Population: Normalized Testosterone measured at the end of the 16th week Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm

Normalized at \>350ng/dl

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Normalized Testosterone - Week 16 Patients 1-6	437 ng/dl	591 ng/dl	338 ng/dl	391 ng/dl	696 ng/dl	502 ng/dl
Normalized Testosterone - Week 16 Patients 7-12	337 ng/dl	200 ng/dl	451 ng/dl	403 ng/dl	396 ng/dl	520 ng/dl
Normalized Testosterone - Week 16 Patients 13-18	329 ng/dl	191 ng/dl	124 ng/dl	206 ng/dl	585 ng/dl	283 ng/dl
Normalized Testosterone - Week 16 Patients 19-24	609 ng/dl	323 ng/dl	456 ng/dl	288 ng/dl	—	484 ng/dl

SECONDARY outcome

Timeframe: Week 24

Population: Normalized Testosterone measured at the end of the 24th week Data was not collected for patient 15 clomiphene-anastrazole-placebo Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene

Normalized at \>350ng/dl

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Normalized Testosterone - Week 24 Patients 1-6	268 ng/dl	793 ng/dl	214 ng/dl	537 ng/dl	412 ng/dl	596 ng/dl
Normalized Testosterone - Week 24 Patients 7-12	269 ng/dl	519 ng/dl	440 ng/dl	531 ng/dl	375 ng/dl	972 ng/dl
Normalized Testosterone - Week 24 Patients 13-18	446 ng/dl	449 ng/dl	—	447 ng/dl	487 ng/dl	195 ng/dl
Normalized Testosterone - Week 24 Patients 19-24	196 ng/dl	630 ng/dl	274 ng/dl	486 ng/dl	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Initial Evaluation for ADAM score - Week 0

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
ADAM (Androgen Deficiency in the Aging Male) Score - Screen Patients 13-18	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Screen Patients 19-24	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Screen Patients 1-6	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Screen Patients 7-12	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale

SECONDARY outcome

Timeframe: Week 8

Population: ADAM score at the end of Week 8 Data was not collected for patient 19 in anastrazole-clomiphene-placebo arm

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=3 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 Patients 1-6	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 Patients 7-12	1 score on a scale	1 score on a scale	0 score on a scale	1 score on a scale	0 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 Patients 13-18	1 score on a scale	0 score on a scale	1 score on a scale	0 score on a scale	0 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 Patients 19-24	—	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale

SECONDARY outcome

Timeframe: Week 16

Population: ADAM score at the end of Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 Patients 1-6	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	0 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 Patients 7-12	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 Patients 13-18	1 score on a scale	1 score on a scale	1 score on a scale	0 score on a scale	0 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 Patients 19-24	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	—	1 score on a scale

SECONDARY outcome

Timeframe: Week 24

Population: ADAM score at the end of Week 24 No data collected pt 15 in clomiphene-anastrazole-placebo arm no data collected for pt 16 clomiphene-placebo-anastrazole arm no data collected for pt 23 placebo-clomiphene-anastrazole arm

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=3 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 Patients 1-6	1 score on a scale	0 score on a scale	0 score on a scale	1 score on a scale	0 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 Patients 7-12	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 Patients 13-18	0 score on a scale	0 score on a scale	—	—	1 score on a scale	1 score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 Patients 19-24	1 score on a scale	1 score on a scale	1 score on a scale	0 score on a scale	—	1 score on a scale

SECONDARY outcome

Timeframe: Baseline

Population: Score 0-4 at the initial encounter week 0

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
EHS (Erectile Hardness Score) - Screen Patients 1-6	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	3 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Screen Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	3 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Screen Patients 13-18	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	1 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Screen Patients 19-24	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale

SECONDARY outcome

Timeframe: Week 8

Population: Score 0-4 at the end of Week 8

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
EHS (Erectile Hardness Score) - Week 8 Patients 1-6	1 score on a scale	4 score on a scale	1 score on a scale	1 score on a scale	3 score on a scale	1 score on a scale
EHS (Erectile Hardness Score) - Week 8 Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	4 score on a scale	2 score on a scale
EHS (Erectile Hardness Score) - Week 8 Patients 13-18	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	1 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Week 8 Patients 19-24	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	1 score on a scale	3 score on a scale

SECONDARY outcome

Timeframe: Week 16

Population: Score 0-4 at the end of Week 16 Data for patient 23 was not collected in placebo-clomiphene-anastrazole arm

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
EHS (Erectile Hardness Score) - Week 16 Patients 1-6	3 score on a scale	3 score on a scale	2 score on a scale	2 score on a scale	4 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Week 16 Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Week 16 Patients 13-18	3 score on a scale	4 score on a scale	3 score on a scale	4 score on a scale	1 score on a scale	0 score on a scale
EHS (Erectile Hardness Score) - Week 16 Patients 19-24	3 score on a scale	1 score on a scale	3 score on a scale	3 score on a scale	—	1 score on a scale

SECONDARY outcome

Timeframe: Week 24

Population: Score 0-4 at the end of Week 24 no data was collected for patient 15 in clomiphene-anastrazole-placebo no data was collected for patient 23 in placebo-clomiphene-anastrazole

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
EHS (Erectile Hardness Score) - Week 24 Patients 13-18	3 score on a scale	4 score on a scale	—	4 score on a scale	1 score on a scale	1 score on a scale
EHS (Erectile Hardness Score) - Week 24 Patients 19-24	3 score on a scale	1 score on a scale	3 score on a scale	3 score on a scale	—	1 score on a scale
EHS (Erectile Hardness Score) - Week 24 Patients 1-6	3 score on a scale	4 score on a scale	2 score on a scale	2 score on a scale	3 score on a scale	3 score on a scale
EHS (Erectile Hardness Score) - Week 24 Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	2 score on a scale	2 score on a scale	3 score on a scale

SECONDARY outcome

Timeframe: Baseline

Population: LH measured at initial encounter Data for pt 23 in placebo-clomiphene-anastrazole not collected

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
LH - Screen Patients 1-6	3.5 IU/L	3.6 IU/L	3.8 IU/L	6.8 IU/L	3.5 IU/L	3.4 IU/L
LH - Screen Patients 7-12	3.4 IU/L	3.8 IU/L	2.4 IU/L	4.1 IU/L	2.4 IU/L	1.7 IU/L
LH - Screen Patients 13-18	1.1 IU/L	3.5 IU/L	4.1 IU/L	3.3 IU/L	6 IU/L	3.1 IU/L
LH - Screen Patients 19-24	6.3 IU/L	4.1 IU/L	4.7 IU/L	5.9 IU/L	—	6.8 IU/L

SECONDARY outcome

Timeframe: Week 8

Population: LH measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
LH - Week 8 Patients 13-18	2.9 IU/L	6.9 IU/L	6.1 IU/L	4.7 IU/L	6.7 IU/L	3 IU/L
LH - Week 8 Patients 1-6	9.1 IU/L	5.1 IU/L	9.9 IU/L	17.3 IU/L	3.6 IU/L	6.3 IU/L
LH - Week 8 Patients 7-12	5.2 IU/L	4 IU/L	10.7 IU/L	12.6 IU/L	3.3 IU/L	1.9 IU/L
LH - Week 8 Patients 19-24	4.2 IU/L	11.5 IU/L	7.5 IU/L	6.9 IU/L	—	7.3 IU/L

SECONDARY outcome

Timeframe: Week 16

Population: LH measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
LH - Week 16 Patients 7-12	6.9 IU/L	4.8 IU/L	6.3 IU/L	4.9 IU/L	5.2 IU/L	3.8 IU/L
LH - Week 16 Patients 13-18	1.9 IU/L	2.1 IU/L	2.2 IU/L	1.9 IU/L	13 IU/L	6.4 IU/L
LH - Week 16 Patients 19-24	7.8 IU/L	4.3 IU/L	6.6 IU/L	4.9 IU/L	—	7.4 IU/L
LH - Week 16 Patients 1-6	6.8 IU/L	4.6 IU/L	4.2 IU/L	5.4 IU/L	13.9 IU/L	8.9 IU/L

SECONDARY outcome

Timeframe: Week 24

Population: LH measured at week 24 No data for patient 13 collected in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
LH - Week 24 Patients 1-6	3 IU/L	4.1 IU/L	3.4 IU/L	6.4 IU/L	5 IU/L	7.7 IU/L
LH - Week 24 Patients 7-12	6.1 IU/L	12.6 IU/L	5.9 IU/L	6.4 IU/L	2.9 IU/L	10.5 IU/L
LH - Week 24 Patients 13-18	2.2 IU/L	5.4 IU/L	—	7.6 IU/L	7.1 IU/L	8.1 IU/L
LH - Week 24 Patients 19-24	2.7 IU/L	15.1 IU/L	4.7 IU/L	5.4 IU/L	—	—

SECONDARY outcome

Timeframe: Baseline

Population: FSH measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Values for follicle stimulating hormone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
FSH - Screen Patients 1-6	2.7 IU/L	2.4 IU/L	5.5 IU/L	4.5 IU/L	3.3 IU/L	3.6 IU/L
FSH - Screen Patients 7-12	5.7 IU/L	3.7 IU/L	3.9 IU/L	2.9 IU/L	1.8 IU/L	3.5 IU/L
FSH - Screen Patients 13-18	1.6 IU/L	5.1 IU/L	1.7 IU/L	4 IU/L	4.4 IU/L	5.7 IU/L
FSH - Screen Patients 19-24	5.5 IU/L	10 IU/L	4.5 IU/L	4.4 IU/L	—	5.1 IU/L

SECONDARY outcome

Timeframe: Week 8

Population: FSH measured at Week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Values for follicle stimulating hormone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
FSH - Week 8 Patients 1-6	5.4 IU/L	4.3 IU/L	8.2 IU/L	16.2 IU/L	3.4 IU/L	4.1 IU/L
FSH - Week 8 Patients 7-12	7.7 IU/L	6.2 IU/L	7.8 IU/L	3.03 IU/L	2.2 IU/L	4.2 IU/L
FSH - Week 8 Patients 13-18	3 IU/L	8.3 IU/L	1.8 IU/L	6.3 IU/L	4.7 IU/L	6 IU/L
FSH - Week 8 Patients 19-24	11.3 IU/L	20.3 IU/L	6.1 IU/L	8.1 IU/L	—	4.4 IU/L

SECONDARY outcome

Timeframe: Week 16

Population: FSH measured at Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Values for follicle stimulating hormone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
FSH - Week 16 Patients 13-18	1.9 IU/L	3.8 IU/L	1.2 IU/L	3.3 IU/L	8.3 IU/L	11.5 IU/L
FSH - Week 16 Patients 19-24	12.8 IU/L	11.4 IU/L	6.2 IU/L	4.2 IU/L	—	8.9 IU/L
FSH - Week 16 Patients 1-6	7 IU/L	4.3 IU/L	4.2 IU/L	5.3 IU/L	10.7 IU/L	6.8 IU/L
FSH - Week 16 Patients 7-12	7.2 IU/L	3.7 IU/L	6 IU/L	2.9 IU/L	2.6 IU/L	6.5 IU/L

SECONDARY outcome

Timeframe: Week 24

Population: FSH measured at Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Lab Values for follicle stimulating hormone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
FSH - Week 24 Patients 1-6	4.1 IU/L	4.8 IU/L	3 IU/L	5.2 IU/L	6.5 IU/L	4 IU/L
FSH - Week 24 Patients 7-12	4.4 IU/L	15.1 IU/L	6 IU/L	3.7 IU/L	5.2 IU/L	14.5 IU/L
FSH - Week 24 Patients 13-18	2 IU/L	7.2 IU/L	—	7.2 IU/L	5.9 IU/L	10.4 IU/L
FSH - Week 24 Patients 19-24	4.8 IU/L	29.7 IU/L	5 IU/L	5.8 IU/L	—	—

SECONDARY outcome

Timeframe: Baseline

Population: FT measured at initial encounter Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measure of Free Testosterone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Free Testosterone - Screen Patients 19-24	2.19 ng/dl	7.27 ng/dl	6.52 ng/dl	7.71 ng/dl	—	6.33 ng/dl
Free Testosterone - Screen Patients 1-6	8.4 ng/dl	6.99 ng/dl	7.28 ng/dl	8.82 ng/dl	6.27 ng/dl	7.86 ng/dl
Free Testosterone - Screen Patients 7-12	6.74 ng/dl	9.31 ng/dl	6.07 ng/dl	9.9 ng/dl	5.82 ng/dl	5.78 ng/dl
Free Testosterone - Screen Patients 13-18	9.56 ng/dl	12.27 ng/dl	—	4.86 ng/dl	9.49 ng/dl	—

SECONDARY outcome

Timeframe: Week 8

Population: FT measured at the end of Week 8 Data was not collected for patient 8 in anastrazole-placebo-clomiphene arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measure of Free Testosterone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=3 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Free Testosterone - Week 8 Patients 1-6	19.46 ng/dl	21.8 ng/dl	17.72 ng/dl	35.27 ng/dl	2.71 ng/dl	12.3 ng/dl
Free Testosterone - Week 8 Patients 7-12	15.63 ng/dl	—	19.33 ng/dl	27.79 ng/dl	9.4 ng/dl	5.3 ng/dl
Free Testosterone - Week 8 Patients 13-18	21.61 ng/dl	15.18 ng/dl	—	21.71 ng/dl	8.91 ng/dl	—
Free Testosterone - Week 8 Patients 19-24	17.44 ng/dl	20.01 ng/dl	11.37 ng/dl	15.71 ng/dl	—	6.04 ng/dl

SECONDARY outcome

Timeframe: Week 16

Population: FT measured at the end of Week 16 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 22 in clomiphene-placebo-anastrazole arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measure of Free Testosterone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=3 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Free Testosterone - Week 16 Patients 1-6	14.16 ng/dl	16.37 ng/dl	12.27 ng/dl	12.67 ng/dl	19.21 ng/dl	17.47 ng/dl
Free Testosterone - Week 16 Patients 7-12	8.83 ng/dl	5.7 ng/dl	14.7 ng/dl	9.63 ng/dl	14.57 ng/dl	13.47 ng/dl
Free Testosterone - Week 16 Patients 13-18	10.17 ng/dl	5.98 ng/dl	—	6.63 ng/dl	16.38 ng/dl	7.58 ng/dl
Free Testosterone - Week 16 Patients 19-24	14.98 ng/dl	9.46 ng/dl	11.22 ng/dl	—	—	11.62 ng/dl

SECONDARY outcome

Timeframe: Week 24

Population: FT measured at the end of Week 24 Data not collected for patient 8 in APC arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm No data collected pt 24 in PAC arm

Measure of Free Testosterone

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=3 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=2 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Free Testosterone - Week 24 Patients 7-12	6.11 ng/dl	—	11.09 ng/dl	17.89 ng/dl	11.63 ng/dl	25.27 ng/dl
Free Testosterone - Week 24 Patients 13-18	11.82 ng/dl	13.74 ng/dl	—	18.19 ng/dl	15.49 ng/dl	—
Free Testosterone - Week 24 Patients 19-24	5.82 ng/dl	13.54 ng/dl	6.11 ng/dl	16.82 ng/dl	—	—
Free Testosterone - Week 24 Patients 1-6	10.51 ng/dl	19.35 ng/dl	6.25 ng/dl	11.28 ng/dl	8.65 ng/dl	19.31 ng/dl

SECONDARY outcome

Timeframe: Baseline

Population: Estradiol measurement at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Estradiol - Screen Patients 19-24	9.5 pg/mL	15.5 pg/mL	26.6 pg/mL	11 pg/mL	—	26.8 pg/mL
Estradiol - Screen Patients 13-18	13.3 pg/mL	20.1 pg/mL	16.2 pg/mL	14.1 pg/mL	15.9 pg/mL	13.1 pg/mL
Estradiol - Screen Patients 1-6	21.6 pg/mL	8.1 pg/mL	9.6 pg/mL	13.5 pg/mL	15.9 pg/mL	18.4 pg/mL
Estradiol - Screen Patients 7-12	9 pg/mL	19.3 pg/mL	21.3 pg/mL	11.4 pg/mL	18.6 pg/mL	10.9 pg/mL

SECONDARY outcome

Timeframe: Week 8

Population: Estradiol measurement at the end of Week 8 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=3 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Estradiol - Week 8 Patients 1-6	11.2 pg/mL	—	49.8 pg/mL	94.5 pg/mL	20.8 pg/mL	22.5 pg/mL
Estradiol - Week 8 Patients 13-18	9.7 pg/mL	4.9 pg/mL	25.1 pg/mL	33.5 pg/mL	10 pg/mL	15.9 pg/mL
Estradiol - Week 8 Patients 19-24	7.4 pg/mL	10.7 pg/mL	51.7 pg/mL	39.1 pg/mL	—	27.4 pg/mL
Estradiol - Week 8 Patients 7-12	7 pg/mL	15.1 pg/mL	70.1 pg/mL	45 pg/mL	18.5 pg/mL	9.3 pg/mL

SECONDARY outcome

Timeframe: Week 16

Population: Estradiol measurement at the end of Week 16 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=3 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Estradiol - Week 16 Patients 1-6	39.5 pg/mL	—	8.9 pg/mL	17.9 pg/mL	56.9 pg/mL	5 pg/mL
Estradiol - Week 16 Patients 7-12	13.1 pg/mL	21.6 pg/mL	12.8 pg/mL	14.4 pg/mL	28.2 pg/mL	6.8 pg/mL
Estradiol - Week 16 Patients 13-18	20.1 pg/mL	15 pg/mL	23.8 pg/mL	13.1 pg/mL	37 pg/mL	4.9 pg/mL
Estradiol - Week 16 Patients 19-24	48.5 pg/mL	28.3 pg/mL	14.8 pg/mL	15.9 pg/mL	—	4.9 pg/mL

SECONDARY outcome

Timeframe: Week 24

Population: Estradiol measurement at the end of Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Estradiol - Week 24 Patients 1-6	22.5 pg/mL	43.9 pg/mL	16.2 pg/mL	9.5 pg/mL	18.1 pg/mL	41.1 pg/mL
Estradiol - Week 24 Patients 7-12	12.5 pg/mL	49.1 pg/mL	6.6 pg/mL	5 pg/mL	11.6 pg/mL	85.9 pg/mL
Estradiol - Week 24 Patients 13-18	25.5 pg/mL	36.4 pg/mL	—	9.2 pg/mL	4.9 pg/mL	29.3 pg/mL
Estradiol - Week 24 Patients 19-24	22.2 pg/mL	39.4 pg/mL	19 pg/mL	4.9 pg/mL	—	—

SECONDARY outcome

Timeframe: Baseline

Population: SHBG measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SHBG - Screen Patients 1-6	13.9 nmol/L	35.2 nmol/L	20 nmol/L	31.7 nmol/L	26.2 nmol/L	24.1 nmol/L
SHBG - Screen Patients 7-12	30.7 nmol/L	12.6 nmol/L	23.5 nmol/L	26.4 nmol/L	20.9 nmol/L	26.8 nmol/L
SHBG - Screen Patients 13-18	23.5 nmol/L	17.5 nmol/L	21.4 nmol/L	20 nmol/L	16.9 nmol/L	14.8 nmol/L
SHBG - Screen Patients 19-24	28.6 nmol/L	22 nmol/L	35.5 nmol/L	11.6 nmol/L	—	30.6 nmol/L

SECONDARY outcome

Timeframe: Week 8

Population: SHBG measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SHBG - Week 8 Patients 1-6	10 nmol/L	38.2 nmol/L	18.4 nmol/L	29.8 nmol/L	23.9 nmol/L	21.6 nmol/L
SHBG - Week 8 Patients 7-12	23.4 nmol/L	12.7 nmol/L	26 nmol/L	27.2 nmol/L	24.1 nmol/L	25.7 nmol/L
SHBG - Week 8 Patients 13-18	26.9 nmol/L	16.1 nmol/L	21.6 nmol/L	30.9 nmol/L	14.3 nmol/L	17.6 nmol/L
SHBG - Week 8 Patients 19-24	28.1 nmol/L	20.1 nmol/L	42.7 nmol/L	20.9 nmol/L	—	30.7 nmol/L

SECONDARY outcome

Timeframe: Week 16

Population: SHBG measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SHBG - Week 16 Patients 1-6	22.3 nmol/L	35.5 nmol/L	13.8 nmol/L	16.4 nmol/L	33.3 nmol/L	17.7 nmol/L
SHBG - Week 16 Patients 7-12	30.7 nmol/L	15.3 nmol/L	26.6 nmol/L	31 nmol/L	16.7 nmol/L	23 nmol/L
SHBG - Week 16 Patients 13-18	26.8 nmol/L	17.2 nmol/L	14.2 nmol/L	22.8 nmol/L	17.2 nmol/L	16.6 nmol/L
SHBG - Week 16 Patients 19-24	39.3 nmol/L	24.8 nmol/L	35 nmol/L	13.9 nmol/L	—	31 nmol/L

SECONDARY outcome

Timeframe: Week 24

Population: SHBG measured at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=3 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=3 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SHBG - Week 24 Patients 1-6	14.6 nmol/L	41.8 nmol/L	15.1 nmol/L	25.2 nmol/L	29.7 nmol/L	23.6 nmol/L
SHBG - Week 24 Patients 7-12	33.8 nmol/L	16 nmol/L	24.4 nmol/L	25.3 nmol/L	13.8 nmol/L	34.1 nmol/L
SHBG - Week 24 Patients 13-18	29 nmol/L	21.7 nmol/L	—	20.1 nmol/L	17.3 nmol/L	17.5 nmol/L
SHBG - Week 24 Patients 19-24	23.2 nmol/L	26 nmol/L	33.8 nmol/L	13.7 nmol/L	—	—

SECONDARY outcome

Timeframe: Baseline

Population: SEP measured at the initial encounter Baseline SPEP was not measured for participants 1-24 Table included for completeness

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 8

Population: SEP measured at the end of week 8 data not collected for pt 11,17 in PCA arm data not collected for pt 13 in ACP arm data not collected for pt 15 in CAP arm data not collected for pt 22 in CPA arm

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=3 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=3 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=3 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=2 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SEP #1-3 Cumulative - Week 8 Patients 1-6	3 score on a scale	3 score on a scale	1 score on a scale	1 score on a scale	3 score on a scale	4 score on a scale
SEP #1-3 Cumulative - Week 8 Patients 7-12	2 score on a scale	3 score on a scale	2 score on a scale	2 score on a scale	—	3 score on a scale
SEP #1-3 Cumulative - Week 8 Patients 13-18	—	2 score on a scale	—	1 score on a scale	—	2 score on a scale
SEP #1-3 Cumulative - Week 8 Patients 19-24	3 score on a scale	3 score on a scale	3 score on a scale	—	1 score on a scale	2 score on a scale

SECONDARY outcome

Timeframe: Week 16

Population: SEP measured at the end of week 16 data not collected for pt 3,15 in CAP arm data not collected for pt 5,11,23 in PCA arm

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=4 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=2 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=1 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SEP #1-3 Cumulative - Week 16 Patients 1-6	2 score on a scale	3 score on a scale	—	1 score on a scale	—	2 score on a scale
SEP #1-3 Cumulative - Week 16 Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	—	0 score on a scale
SEP #1-3 Cumulative - Week 16 Patients 13-18	4 score on a scale	3 score on a scale	—	3 score on a scale	3 score on a scale	2 score on a scale
SEP #1-3 Cumulative - Week 16 Patients 19-24	3 score on a scale	3 score on a scale	3 score on a scale	3 score on a scale	—	1 score on a scale

SECONDARY outcome

Timeframe: Week 24

Population: SEP measured at the end of week 24 data not collected for pt 1,13 in ACP arm data not collected for pt 3, 15 in CAP arm data not collected for pt 22 in CPA arm data not collected for pt 11,23 PCA arm

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Outcome measures

Outcome measures
Measure	Anastrazole-clomiphene-placebo n=2 Participants anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 Participants anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=2 Participants clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=3 Participants clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=2 Participants placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 Participants placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
SEP #1-3 Cumulative - Week 24 Patients 1-6	—	3 score on a scale	—	3 score on a scale	3 score on a scale	2 score on a scale
SEP #1-3 Cumulative - Week 24 Patients 7-12	3 score on a scale	3 score on a scale	3 score on a scale	1 score on a scale	—	0 score on a scale
SEP #1-3 Cumulative - Week 24 Patients 13-18	—	3 score on a scale	—	2 score on a scale	0 score on a scale	2 score on a scale
SEP #1-3 Cumulative - Week 24 Patients 19-24	3 score on a scale	3 score on a scale	3 score on a scale	—	—	1 score on a scale

Adverse Events

Anastrazole-clomiphene-placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Anastrazole-placebo-clomiphene

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Clomiphene-anastrazole-placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Clomiphene-placebo-anastrazole

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo-clomiphene-anastrazole

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo-anastrazole-clomiphene

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anastrazole-clomiphene-placebo n=4 participants at risk anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 participants at risk anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 participants at risk clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 participants at risk clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 participants at risk placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 participants at risk placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Infections and infestations Lyme Disease	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.

Other adverse events

Other adverse events
Measure	Anastrazole-clomiphene-placebo n=4 participants at risk anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Anastrazole-placebo-clomiphene n=4 participants at risk anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-anastrazole-placebo n=4 participants at risk clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Clomiphene-placebo-anastrazole n=4 participants at risk clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-clomiphene-anastrazole n=4 participants at risk placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	Placebo-anastrazole-clomiphene n=4 participants at risk placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
General disorders Headache	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Musculoskeletal and connective tissue disorders Osteopenia	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Musculoskeletal and connective tissue disorders Rib Pain	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
General disorders Nasal Septal Deviation	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Musculoskeletal and connective tissue disorders Left Shoulder Pain	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Infections and infestations Upper Respiratory Infection (URI)	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Endocrine disorders Vitamin D deficiency	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Nervous system disorders Dizziness	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
General disorders Insomnia	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
General disorders Fatigue	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Endocrine disorders Weight Gain	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Endocrine disorders Decreased Libido	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Gastrointestinal disorders Bloated	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Respiratory, thoracic and mediastinal disorders Chronic Maxillary Sinusitis	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Musculoskeletal and connective tissue disorders Right Big Toe Pain	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
Infections and infestations Ringworm	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	0.00% 0/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.	25.0% 1/4 • Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting. The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.

Additional Information

Dr. Charles Welliver

Albany Medical Center

Phone: 518-262-3341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place