Status:
COMPLETED
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University of Rochester
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
12-18 years
Phase:
PHASE3
Brief Summary
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to pl...
Detailed Description
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwante...
Eligibility Criteria
Inclusion
- Menstrual irregularity defined as cycle length \> 45 days
- Overweight as BMI \> 25
- Clinical evidence of hirsuitism or acne
- Testosterone \> 50ng/dL
Exclusion
- History of diabetes mellitus
- History of Cushing's disease
- History of hyperprolactinemia
- Untreated hypo or hyperthyroidism
- History of adrenal hyperplasia
- Significant renal impairment
- Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
- Exercise \> 10 hours per week
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00714233
Start Date
August 1 2002
End Date
December 1 2007
Last Update
May 15 2015
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