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Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)

Phase 3
12 Years
18 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic
anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although
signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is
often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting
in a more severe clinical picture. Obesity among adolescents has been increasing in recent
years, with overrepresentation of females who show evidence of hyperandrogenism and
irregular periods, suggesting an association of obesity and PCOS at an early age. Recent
data, however, have drawn attention to the long-term risks of PCOS, including diabetes and
cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of
PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk
of diabetes and heart disease. Traditional treatments with oral contraceptives are
associated with reduction in serum androgens and improvements in menstrual cycles in
adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral
contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address
the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve
metabolic features of PCOS, but combination therapy with oral contraceptives has never been
studied in the obese adolescent with PCOS.

The major hypothesis of this proposal is that metformin will improve the metabolic profile
of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a
secondary hypothesis will be that compliance with a concurrent lifestyle modification
program with be associated with the most significant improvements.

Inclusion Criteria:

Age 12-18 years; Menstrual irregularity; Overweight; Must be able to
swallow capsules; At lease 6 months since onset of first menstrual cycle.

Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar
Disease; Contraindication to exercise; Weight > 300 lbs.

Type of Study:


Study Design:

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

Outcome Measure:

Reduction in Abdominal Fat as Measured by Waist Circumference.

Outcome Description:

Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention

Outcome Time Frame:

baseline and 24 weeks

Safety Issue:


Principal Investigator

Kathleen Hoeger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

January 2008

Related Keywords:

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



University of Rochester Medical Center Rochester, New York  14642