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The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Phase 2
12 Years
39 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is
also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a
variety of non-hospital based populations have provided evidence that the incidence of
hyperandrogenic chronic anovulation is in the range of 4-6% of the female population.
Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or
through pharmaceutical intervention, have consistently resulted in a marked improvement in
the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult
female population is to determine that combination therapy will improve ovulatory frequency.
Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then
single agent therapy. The primary objective of the adolescent population is to determine
that the combination therapy will improve hyperandrogenemia. Secondary objective is to
improve ovulatory frequency and insulin sensitivity than just the use of a single agent

Inclusion Criteria:

- Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of
8 or less periods per year

- Elevated testosterone levels

- General good health

- Off of current medications which may confound response to study medications

Exclusion Criteria:

- Pregnancy

- Lactose Intolerance

- Medical Contraindications

- Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood

- Diabetes, liver, heart, kidney or uncorrected thyroid disease

Type of Study:


Study Design:

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

Outcome Measure:

Change in Testosterone After 6 Months of Treatment

Outcome Description:

The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy.

Outcome Time Frame:

baseline and 6 months

Safety Issue:


Principal Investigator

Richard Legro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

March 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome (PCOS)
  • Anovulation
  • Elevated Testosterone
  • Polycystic Ovary Syndrome



Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033