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

EMD Serono1 site in 1 country271 target enrollmentMarch 10, 2005

ConditionsAnovulation

InterventionsAnastrozole 5 mg Anastrozole 1 mg Clomiphene Citrate 50 mg Clomiphene Citrate 100 mg Anastrozole 10 mg

DrugsAnastrozole 1 mg Anastrozole 5 mg Anastrozole 10 mg Clomiphene Citrate 50 mg Clomiphene Citrate 100 mg

Overview

Phase: Phase 2
Intervention: Anastrozole 5 mg
Conditions: Anovulation
Sponsor: EMD Serono
Enrollment: 271
Locations: 1
Primary Endpoint: Ovulation Rate in Cycle 1
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 10, 2005

End Date

December 12, 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

EMD Serono

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Anastrozole 5 mg

Intervention: Anastrozole 5 mg

Anastrozole 1 mg

Intervention: Anastrozole 1 mg

Clomiphene Citrate 50 Milligram (mg)

Intervention: Clomiphene Citrate 50 mg

Clomiphene Citrate 100 mg

Intervention: Clomiphene Citrate 100 mg

Anastrozole 10 mg

Intervention: Anastrozole 10 mg

Outcomes

Primary Outcomes

Ovulation Rate in Cycle 1

Time Frame: Up to 1 month

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).