Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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 placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

1. reduce fasting glucose levels

2. reduce androgen hormone levels

3. improve sex steroid binding, and

4. improve lipids (fatty substances in the blood)

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Drospirenone and ethinyl estradiol combination; Metformin

Criteria

Inclusion Criteria:

• Menstrual irregularity defined as cycle length > 45 days

• Overweight as BMI > 25

• Clinical evidence of hirsuitism or acne

• Testosterone > 50ng/dL

Exclusion Criteria:

• 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