At a glance
ClinicalIndex Comparison Record- ✓Age 18-40 years
- ✓Ovulatory dysfunction with irregular and/or extended menstrual cycles
- ✓Non-smoker
- ✕Prior gonadotropin treatment is not allowed
- ✕More than 6 previous clomiphene treatment cycles
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Anastrozole 1 mg, Anastrozole 5 mg, and 3 other interventions for Anovulation. Completed, enrolled 271 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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).
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).
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).
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).
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).