Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
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 unwanted hair growth or acne. This condition often becomes recognized at the time
of puberty. The standard treatment for this condition is oral contraceptive pills, which are
used not for contraception, but to cause a regular, monthly bleeding pattern.
Many adolescents with PCOS have increased levels of insulin, a hormone that controls the
body's sugar balance. These increased insulin levels may play a role in the development of
polycystic ovary syndrome. There are several medications now available, which can decrease
the insulin levels by improving the action of insulin in the body. Metformin is one of these
drugs. Metformin is a drug currently used in the management of diabetes to control blood
sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic
ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be
reversed or diminished.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
24 week
No
Kathleen M Hoeger, MD
Principal Investigator
University of Rochester
United States: Food and Drug Administration
RSRB # 09354
NCT00714233
August 2002
December 2007
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