Trial Outcomes & Findings for PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (NCT NCT01327495)

NCT ID: NCT01327495

Last Updated: 2017-10-05

Results Overview

To measure intraprostatic dihydrotestosterone \[DHT\] levels

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-10-05

Participant Flow

Healthy males, 25-55 years old, were recruited via advertisement: flyers and newspaper ads at the University of Washington.

98 screened. 28 screen fails (or did not finish screen). 8 subjects dropped out prior to drug start. 62 subjects started drug. 7 subjects dropped after drug start/pre-drug finish. 2 dropped after finishing study drug, but prior to prostate biopsy. 2 subjects dropped from analysis for non-compliance. 51 completed entire study, included in analysis.

Participant milestones

Measure	Arm 1 (Placebo Acyline & Placebo T Gel ) Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks placebo acyline: Placebo acyline subcutaneous injection every 2 weeks placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks	Arm 2 (Acyline & 1.25g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 3 (Acyline & 2.5g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 4 (Acyline & 5g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 5 (Acyline & 10g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 6 (Acyline & 15g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks
Overall Study STARTED	10	11	10	9	11	11
Overall Study COMPLETED	8	9	8	9	8	9
Overall Study NOT COMPLETED	2	2	2	0	3	2

Reasons for withdrawal

Measure	Arm 1 (Placebo Acyline & Placebo T Gel ) Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks placebo acyline: Placebo acyline subcutaneous injection every 2 weeks placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks	Arm 2 (Acyline & 1.25g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 3 (Acyline & 2.5g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 4 (Acyline & 5g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 5 (Acyline & 10g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 6 (Acyline & 15g Testosterone Gel) Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks
Overall Study Adverse Event	2	1	1	0	0	2
Overall Study Withdrawal by Subject	0	1	1	0	1	0
Overall Study Physician Decision	0	0	0	0	2	0

Baseline Characteristics

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

Baseline characteristics by cohort

Measure	Arm 1 n=8 Participants Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks placebo acyline: Placebo acyline subcutaneous injection every 2 weeks placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks	Arm 2 n=9 Participants Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 3 n=8 Participants Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 4 n=9 Participants Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 5 n=8 Participants Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 6 n=9 Participants Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Total n=51 Participants Total of all reporting groups
Age, Continuous	45 years n=5 Participants	45 years n=7 Participants	46 years n=5 Participants	34 years n=4 Participants	42 years n=21 Participants	51 years n=8 Participants	44 years n=8 Participants
Sex/Gender, Customized Male	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	9 Participants n=8 Participants	51 Participants n=8 Participants
Body Mass Index (BMI)	28 kg^m2 n=5 Participants	28 kg^m2 n=7 Participants	26 kg^m2 n=5 Participants	25 kg^m2 n=4 Participants	25 kg^m2 n=21 Participants	26 kg^m2 n=8 Participants	26 kg^m2 n=8 Participants
Testosterone Level	450 ng/dL n=5 Participants	448 ng/dL n=7 Participants	554 ng/dL n=5 Participants	419 ng/dL n=4 Participants	482 ng/dL n=21 Participants	452 ng/dL n=8 Participants	459 ng/dL n=8 Participants
DHT Level	36 ng/dL n=5 Participants	37 ng/dL n=7 Participants	43 ng/dL n=5 Participants	39 ng/dL n=4 Participants	49 ng/dL n=21 Participants	36 ng/dL n=8 Participants	40 ng/dL n=8 Participants
Lutenizing Hormone	3.5 mIU/mL n=5 Participants	5 mIU/mL n=7 Participants	4 mIU/mL n=5 Participants	3 mIU/mL n=4 Participants	4 mIU/mL n=21 Participants	3 mIU/mL n=8 Participants	4 mIU/mL n=8 Participants
FSH	5.5 mIU/mL n=5 Participants	4 mIU/mL n=7 Participants	5 mIU/mL n=5 Participants	5 mIU/mL n=4 Participants	5.5 mIU/mL n=21 Participants	7 mIU/mL n=8 Participants	5 mIU/mL n=8 Participants
Hematocrit	43 % n=5 Participants	43 % n=7 Participants	43 % n=5 Participants	44 % n=4 Participants	45 % n=21 Participants	43 % n=8 Participants	43 % n=8 Participants
Prostate Specific Antigen (PSA)	0.80 ng/dL n=5 Participants	0.71 ng/dL n=7 Participants	1.09 ng/dL n=5 Participants	0.74 ng/dL n=4 Participants	0.67 ng/dL n=21 Participants	0.69 ng/dL n=8 Participants	0.75 ng/dL n=8 Participants
Prostate volume	20 cm^3 n=5 Participants	19 cm^3 n=7 Participants	17 cm^3 n=5 Participants	17 cm^3 n=4 Participants	17 cm^3 n=21 Participants	19 cm^3 n=8 Participants	18 cm^3 n=8 Participants
International Prostate Symptom Score (IPSS)	2.5 units on a scale n=5 Participants	1 units on a scale n=7 Participants	2 units on a scale n=5 Participants	0 units on a scale n=4 Participants	1.5 units on a scale n=21 Participants	2 units on a scale n=8 Participants	2 units on a scale n=8 Participants

PRIMARY outcome

Timeframe: 12 weeks

To measure intraprostatic dihydrotestosterone [DHT] levels

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Prostate Tissue DHT Concentrations After Treatment	4.05 ng/g Interval 3.75 to 4.62	4.26 ng/g Interval 2.7 to 5.57	2.99 ng/g Interval 2.57 to 3.79	3.88 ng/g Interval 3.61 to 4.476	4.12 ng/g Interval 2.04 to 6.3	5.11 ng/g Interval 4.4 to 8.69

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Serum Testosterone	4.6 ng/mL Interval 3.1 to 5.0	1.9 ng/mL Interval 1.3 to 3.8	3.4 ng/mL Interval 2.5 to 4.4	3.5 ng/mL Interval 2.9 to 6.4	6.1 ng/mL Interval 2.7 to 9.9	7.7 ng/mL Interval 5.3 to 10.9

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Dihydrotestosterone (DHT)	0.3 ng/mL Interval 0.3 to 0.5	0.6 ng/mL Interval 0.3 to 0.7	0.9 ng/mL Interval 0.5 to 1.2	1.0 ng/mL Interval 0.7 to 1.2	1.5 ng/mL Interval 0.6 to 2.5	1.8 ng/mL Interval 1.0 to 3.6

PRIMARY outcome

Timeframe: 12 weeks

To measure intraprostatic testosterone levels

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Prostate Tissue Testosterone Concentrations After Treatment	0.3 ng/g Interval 0.2275 to 0.535	0.13 ng/g Interval 0.11 to 0.24	0.125 ng/g Interval 0.1075 to 0.165	0.18 ng/g Interval 0.15 to 0.35	0.195 ng/g Interval 0.1275 to 0.77	0.3 ng/g Interval 0.22 to 1.72

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Prostate Specific Antigen	0.82 ng/dL Interval 0.57 to 0.97	0.48 ng/dL Interval 0.44 to 0.62	0.61 ng/dL Interval 0.39 to 0.81	0.58 ng/dL Interval 0.41 to 0.78	0.52 ng/dL Interval 0.43 to 0.67	0.76 ng/dL Interval 0.5 to 1.2

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Prostate Volume	19 cm^3 Interval 18.0 to 22.0	18 cm^3 Interval 14.0 to 22.0	19 cm^3 Interval 15.0 to 21.0	15 cm^3 Interval 14.0 to 17.0	16 cm^3 Interval 15.0 to 20.0	20 cm^3 Interval 16.0 to 20.0

SECONDARY outcome

Timeframe: 12 weeks

IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
International Prostate Symptom Score (IPSS)	1 units on a scale Interval 0.0 to 2.0	2 units on a scale Interval 1.0 to 3.0	2.5 units on a scale Interval 1.5 to 5.25	0 units on a scale Interval 0.0 to 0.0	2.5 units on a scale Interval 1.5 to 7.75	4 units on a scale Interval 1.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
17-OHPreg	1.19 ng/g Interval 1.06 to 1.44	1.25 ng/g Interval 0.93 to 2.07	1.23 ng/g Interval 0.92 to 2.04	1.05 ng/g Interval 1.01 to 1.89	1.02 ng/g Interval 0.94 to 1.45	1.36 ng/g Interval 1.29 to 1.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
17-OHP	0.05 ng/g Interval 0.04 to 0.06	0.05 ng/g Interval 0.05 to 0.06	0.05 ng/g Interval 0.04 to 0.05	0.05 ng/g Interval 0.04 to 0.05	0.05 ng/g Interval 0.04 to 0.05	0.05 ng/g Interval 0.04 to 0.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Androstenedione	0.16 ng/g Interval 0.1 to 0.33	0.11 ng/g Interval 0.1 to 0.18	0.12 ng/g Interval 0.09 to 0.15	0.13 ng/g Interval 0.12 to 0.15	0.18 ng/g Interval 0.15 to 0.28	0.14 ng/g Interval 0.12 to 0.22

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Androsterone	0.17 ng/g Interval 0.14 to 0.21	0.15 ng/g Interval 0.12 to 0.22	0.12 ng/g Interval 0.08 to 0.14	0.17 ng/g Interval 0.11 to 0.24	0.17 ng/g Interval 0.12 to 0.43	0.21 ng/g Interval 0.17 to 0.23

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
DHEA	29.3 ng/g Interval 19.1 to 42.0	26.2 ng/g Interval 13.5 to 35.8	22.1 ng/g Interval 16.2 to 30.1	26.8 ng/g Interval 26.0 to 29.2	24.4 ng/g Interval 23.0 to 28.2	18.6 ng/g Interval 14.7 to 22.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Pregnenolone	28.7 ng/g Interval 23.6 to 33.8	29.5 ng/g Interval 21.3 to 36.4	32.7 ng/g Interval 23.3 to 51.2	32.4 ng/g Interval 28.6 to 45.5	27.9 ng/g Interval 17.4 to 37.6	23.9 ng/g Interval 18.1 to 25.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Measure	Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel n=8 Participants Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \& daily placebo testosterone (T) gel applied transdermally for 12 weeks.	Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.	Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5 n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g n=8 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.	Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g n=9 Participants Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.
Progesterone	0.09 ng/g Interval 0.06 to 0.2	0.08 ng/g Interval 0.06 to 0.09	0.06 ng/g Interval 0.04 to 0.09	0.08 ng/g Interval 0.07 to 0.13	0.09 ng/g Interval 0.08 to 0.12	0.07 ng/g Interval 0.07 to 0.08

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 4

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm 5

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Arm 6

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1 n=10 participants at risk Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks placebo acyline: Placebo acyline subcutaneous injection every 2 weeks placebo gel: daily placebo testosterone gel applied transdermally x 12 weeks	Arm 2 n=11 participants at risk Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks Testosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 3 n=10 participants at risk Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks Testosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 4 n=9 participants at risk Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks Testosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 5 n=11 participants at risk Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks testosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks	Arm 6 n=11 participants at risk Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks testosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks Acyline: 300 ug/kg subcutaneous injection every 2 weeks
Hepatobiliary disorders Abnormal liver funtion tests	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Allergic reaction to Acyline	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Discomfort at injection site	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Hot flashes/night sweats	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	20.0% 2/10 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Insomnia	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Mood changes (irritability)	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Decreased libido	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Increased libido	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Decreased energy, fatigue	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Erectile dysfunction	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Semen changes (decreased ejaculation volume	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Skin changes (acne, rash at site of T gel	20.0% 2/10 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 4 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Nipple discomfort	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Testicular pain	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Sexually transmitted disease	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Headache	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Nausea, vomiting, abnormal bowl movements	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Fever	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Infections and infestations Upper Respiratory infection/symptoms	20.0% 2/10 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 5 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	55.6% 5/9 • Number of events 5 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	27.3% 3/11 • Number of events 3 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Injuries/accidents	20.0% 2/10 • Number of events 3 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	18.2% 2/11 • Number of events 2 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	11.1% 1/9 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	45.5% 5/11 • Number of events 5 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
Endocrine disorders Blood in semen	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.
General disorders Bruise at injection site	10.0% 1/10 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	9.1% 1/11 • Number of events 1 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/10 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/9 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.	0.00% 0/11 • Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period. The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.

Additional Information

Stephanie Page, MD, PhD

University of Washington

Phone: 206-616-0483

Email: page@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place