Status:
COMPLETED
Trial With Metformin in Women With Polycystic Ovary Syndrome
Lead Sponsor:
Herning Hospital
Collaborating Sponsors:
GEA A/S Denmark
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The investigators wanted to elucidate the effects of metformin in Polycystic Ovary Syndrome (PCOS) by performing a randomized, double-blinded, placebo-controlled cross-over study.
Detailed Description
Eligible women who gave written informed consent were assigned to 6 months of treatment with either 850 mg of metformin or placebo twice daily, followed by a wash-out period of 3 months before cross-o...
Eligibility Criteria
Inclusion
- testosterone value above the upper normal limit and
- oligo- or amenorrhea,
Exclusion
- periclimacteric gonadotrophin values,
- hyperprolactinaemia,
- diabetes mellitus,
- impaired thyroid,
- renal or hepatic function,
- hormonal treatment,
- pregnancy,
- lactation or a wish for fertility treatment.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02280057
Start Date
September 1 2001
End Date
December 1 2002
Last Update
February 23 2017
Active Locations (1)
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1
Gynecology Dept. Herning Hospital
Herning, Denmark, 7400