Phase 2
N=271
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Anovulation
Bottom Line
View on ClinicalTrials.gov: NCT00213148 ↗Enrolled (actual)
271
Serious AEs
0.2%
Results posted
Jul 2018
Primary outcome: Primary: Ovulation Rate in Cycle 1 — 64.9; 30.4; 36.8; 35.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anastrozole 1 mg (Drug); Anastrozole 5 mg (Drug); Anastrozole 10 mg (Drug); Clomiphene Citrate 50 mg (Drug); Clomiphene Citrate 100 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- EMD Serono
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ovulation Rate in Cycle 1 |
64.9; 30.4; 36.8; 35.9 | — |
| SECONDARY Number of Subjects With Clinical Pregnancy in Cycle 1 |
10; 4; 7; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00213148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.