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Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Phase 3
12 Years
18 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

Outcome Description:

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

Outcome Time Frame:

24 week

Safety Issue:


Principal Investigator

Kathleen M Hoeger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Food and Drug Administration

Study ID:

RSRB # 09354



Start Date:

August 2002

Completion Date:

December 2007

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Overweight Adolescent Girls
  • Irregular Menstrual Cycles
  • Polycystic Ovary Syndrome