NCT00213148

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anovulation

Interventions

Type	Name	Description
DRUG	Anastrozole 1 mg	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).
DRUG	Anastrozole 5 mg	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).
DRUG	Anastrozole 10 mg	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).
DRUG	Clomiphene Citrate 50 mg	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).
DRUG	Clomiphene Citrate 100 mg	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).

Timeline

• Start date: 2005-03-10
• Primary completion: 2007-12-12
• Completion: 2007-12-12
• First posted: 2005-09-21
• Last updated: 2018-07-17
• Results posted: 2018-07-17

Locations

1 site across 1 country: United States