Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
Information source: Skejby Hospital
Information obtained from ClinicalTrials.gov on May 11, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Metformin (Drug)
Phase: N/A
Status: No longer recruiting
Sponsored by: Skejby Hospital Official(s) and/or principal investigator(s):
Ditte Trolle, MD, Principal Investigator, Affiliation: Skejby University Hospital, Aarhus, Denmark
Summary
Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.
Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.
Clinical Details
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Diagnosis of PCOS
- Age 20 - 45
Exclusion Criteria: Diabetes
- Diabetes
- Hormonal treatment
- Pregnancy, lactation
- Periclimacteric
Locations and Contacts
Additional Information
Starting date:
August 2001
Ending date: September 2004
Last updated: October 10, 2006
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