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Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

NCT00714233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2015-05-15

Study results available
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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)

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

Metformin 425mg. capsules, 2 capsules BID x 24 weeks

DRUG

Oral Contraceptive Pills (Yasmin)

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

BEHAVIORAL

Lifestyle Modification

weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

DRUG

placebo

placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Kathleen M Hoeger, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2004-04-30
Completion
2007-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00714233 on ClinicalTrials.gov