Status:
COMPLETED
The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic, Chronic Oligoovulatory or Anovulatory Women
Lead Sponsor:
59th Medical Wing
Conditions:
Polycystic Ovary Syndrome
Anovulation
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The purpose of our study was to conduct a placebo controlled, double-blind randomized trial in chronic oligoovulatory or anovulatory , hyperandrogenic, infertility patients comparing the effects of ad...
Detailed Description
Women with polycystic ovary syndrome (PCOS), defined as chronic oligoovulation or anovulation and hyperandrogenism, are primarily treated with clomiphene citrate as first line therapy if they desire p...
Eligibility Criteria
Inclusion
- Married
- Hyperandrogenic women 18-40 years old who desired fertility and who demonstrated chronic anovulation or oligoovulation
- Had patent fallopian tubes and whose partners had normal semen analyses were eligible for enrollment in the study.
Exclusion
- Androgen secreting tumours
- Diabetes mellitus
- Thyroid abnormalities
- Hyperprolactinemia
- Adult onset congenital adrenal hyperplasia
- Diminished ovarian reserve
- Subjects who used hormonal medications two months prior to the start of the trial.
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00413179
Start Date
December 1 1997
End Date
April 1 2003
Last Update
December 19 2006
Active Locations (1)
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1
Wiford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236