Status:
COMPLETED
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Lead Sponsor:
University of Rochester
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
12-18 years
Phase:
PHASE3
Brief Summary
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This stu...
Detailed Description
Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the...
Eligibility Criteria
Inclusion
- Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle.
Exclusion
- Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight \> 300 lbs.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00283816
Start Date
January 1 2006
End Date
January 1 2008
Last Update
May 15 2015
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642