Trial Outcomes & Findings for Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction (NCT NCT00213148)

Last Updated: 2018-07-17

Results Overview

Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron \[P4\] level greater than or equal to \[\>=\] 10 nanogram per milliliter \[ng/mL\] and/or pregnancy).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

271 participants

Primary outcome timeframe

Up to 1 month

Results posted on

2018-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Clomiphene Citrate 50 Milligram (mg) Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm.	Clomiphene Citrate 100 mg Subjects from Clomiphene Citrate 50 mg arm who were re-randomized at the start of Cycle 2 and Cycle 3 and were administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month) were presented.	Anastrozole 1 mg Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm.	Anastrozole 5 mg Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm.	Anastrozole 10 mg Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm.
Cycle 1 (1 Month) STARTED	77	0	79	76	39
Cycle 1 (1 Month) COMPLETED	53	0	60	58	17
Cycle 1 (1 Month) NOT COMPLETED	24	0	19	18	22
Cycle 2 (1 Month) STARTED	43	10	42	52	41
Cycle 2 (1 Month) COMPLETED	29	4	28	33	11
Cycle 2 (1 Month) NOT COMPLETED	14	6	14	19	30
Cycle 3 (1 Month) STARTED	23	10	26	24	22
Cycle 3 (1 Month) COMPLETED	23	8	25	23	21
Cycle 3 (1 Month) NOT COMPLETED	0	2	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clomiphene Citrate 50 Milligram (mg) Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm.	Clomiphene Citrate 100 mg Subjects from Clomiphene Citrate 50 mg arm who were re-randomized at the start of Cycle 2 and Cycle 3 and were administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month) were presented.	Anastrozole 1 mg Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm.	Anastrozole 5 mg Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm.	Anastrozole 10 mg Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm.
Cycle 1 (1 Month) Lost to Follow-up	1	0	2	2	1
Cycle 1 (1 Month) Adverse Event	0	0	1	0	0
Cycle 1 (1 Month) Lack of Efficacy	4	0	8	5	8
Cycle 1 (1 Month) Protocol Violation	1	0	1	0	0
Cycle 1 (1 Month) Other	3	0	2	2	7
Cycle 1 (1 Month) Pregnancy Unrelated to Therapy	0	0	0	1	0
Cycle 1 (1 Month) Non Resolving Cyst > 25mm	0	0	0	0	1
Cycle 1 (1 Month) Discontinued Before Start of Cycle 2	15	0	5	8	5
Cycle 2 (1 Month) Lost to Follow-up	0	0	2	2	1
Cycle 2 (1 Month) Lack of Efficacy	1	3	7	6	16
Cycle 2 (1 Month) Other	2	1	2	8	7
Cycle 2 (1 Month) Pregnancy Unrelated to Therapy	0	1	0	0	0
Cycle 2 (1 Month) Non Resolving Cyst > 25mm	1	0	0	0	0
Cycle 2 (1 Month) Discontinued Before Start of Cycle 3	10	1	3	3	6
Cycle 3 (1 Month) Lost to Follow-up	0	2	0	0	1
Cycle 3 (1 Month) Other	0	0	1	1	0

Baseline Characteristics

Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clomiphene Citrate 50 mg n=77 Participants Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Clomiphene Citrate 50 mg or moved to Clomiphene Citrate 100 mg arm.	Anastrozole 1 mg n=79 Participants Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 1 mg or moved to Anastrozole 10 mg arm.	Anastrozole 5 mg n=76 Participants Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Subjects in this arm were re-randomized at the start of Cycle 2 and Cycle 3 and either continued receiving Anastrozole 5 mg or moved to Anastrozole 10 mg arm.	Anastrozole 10 mg n=39 Participants Subjects were administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). Some of the subjects from Anastrozole 1 mg and 5 mg arms were re-randomized at the start of Cycle 2 and Cycle 3 to Anastrozole 10 mg arm.	Total n=271 Participants Total of all reporting groups
Age, Continuous	29.0 years STANDARD_DEVIATION 3.9 • n=5 Participants	28.8 years STANDARD_DEVIATION 3.9 • n=7 Participants	29.6 years STANDARD_DEVIATION 3.9 • n=5 Participants	29.3 years STANDARD_DEVIATION 3.4 • n=4 Participants	29.2 years STANDARD_DEVIATION 3.8 • n=21 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	79 Participants n=7 Participants	76 Participants n=5 Participants	39 Participants n=4 Participants	271 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: All Treated population included all treated subjects who received at least one tablet of study drug (clomiphene citrate or anastrozole).

Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron \[P4\] level greater than or equal to \[\>=\] 10 nanogram per milliliter \[ng/mL\] and/or pregnancy).

Outcome measures

Outcome measures
Measure	Clomiphene Citrate 50 mg n=77 Participants Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1.	Anastrozole 1 mg n=79 Participants Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1.	Anastrozole 5 mg n=76 Participants Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.	Anastrozole 10 mg n=39 Participants Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.
Ovulation Rate in Cycle 1	64.9 percentage of subjects	30.4 percentage of subjects	36.8 percentage of subjects	35.9 percentage of subjects

SECONDARY outcome

Timeframe: Up to 1 month

Population: All Treated population included all treated subjects who received at least one tablet of study drug (CC or anastrozole).

Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.

Outcome measures

Outcome measures
Measure	Clomiphene Citrate 50 mg n=77 Participants Subjects were administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1.	Anastrozole 1 mg n=79 Participants Subjects were administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1.	Anastrozole 5 mg n=76 Participants Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.	Anastrozole 10 mg n=39 Participants Subjects were administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1.
Number of Subjects With Clinical Pregnancy in Cycle 1	10 subjects	4 subjects	7 subjects	0 subjects

Adverse Events

Clomiphene Citrate 50 mg (Cycle 1)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths