Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Phase 2
Completed
- Conditions
- Anovulation
- Interventions
- Registration Number
- NCT00213148
- Lead Sponsor
- EMD Serono
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 271
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anastrozole 1 mg Anastrozole 1 mg - Anastrozole 5 mg Anastrozole 5 mg - Clomiphene Citrate 50 Milligram (mg) Clomiphene Citrate 50 mg - Clomiphene Citrate 100 mg Clomiphene Citrate 100 mg - Anastrozole 10 mg Anastrozole 10 mg -
- Primary Outcome Measures
Name Time Method Ovulation Rate in Cycle 1 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).
- Secondary Outcome Measures
Name Time Method Number of Subjects With Clinical Pregnancy in Cycle 1 Up to 1 month Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.
Trial Locations
- Locations (1)
Local US Medical Information
🇺🇸Rockland, Massachusetts, United States