NCT00213148CompletedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- EMD Serono
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- Ovulation Rate in Cycle 1
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: Anastrozole 5 mg (Drug)
Anastrozole 1 mg
Experimental
Intervention: Anastrozole 1 mg (Drug)
Clomiphene Citrate 50 Milligram (mg)
Active Comparator
Intervention: Clomiphene Citrate 50 mg (Drug)
Clomiphene Citrate 100 mg
Active Comparator
Intervention: Clomiphene Citrate 100 mg (Drug)
Anastrozole 10 mg
Experimental
Intervention: Anastrozole 10 mg (Drug)
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).
Secondary Outcomes
- Number of Subjects With Clinical Pregnancy in Cycle 1(Up to 1 month)
Investigators
Study Sites (1)
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