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

Study Overview
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Brief Summary
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The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.

Official Title
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A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

Conditions
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Anovulation

Intervention / Treatment
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* Drug: Anastrozole 1 mg
* Drug: Anastrozole 5 mg
* Drug: Anastrozole 10 mg
* Drug: Clomiphene Citrate 50 mg
* Drug: Clomiphene Citrate 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-40 years Ovulatory dysfunction characterized by irregular and/or extended cycles Non-smoker Exclusion Criteria: No previous gonadotropin treatment No more than 6 previous clomiphene treatment cycles

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene Citrate 50 Milligram (mg)<br> | Drug: Clomiphene Citrate 50 mg<br>* Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).<br>|
| Active Comparator: Clomiphene Citrate 100 mg<br> | Drug: Clomiphene Citrate 100 mg<br>* Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).<br>|
| Experimental: Anastrozole 1 mg<br> | Drug: Anastrozole 1 mg<br>* Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).<br>|
| Experimental: Anastrozole 5 mg<br> | Drug: Anastrozole 5 mg<br>* Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).<br>|
| Experimental: Anastrozole 10 mg<br> | Drug: Anastrozole 10 mg<br>* Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation Rate in Cycle 1 | 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). | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Clinical Pregnancy in Cycle 1 | Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity. | Up to 1 month |