The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
12 Years
39 Years
Female
Polycystic Ovary Syndrome
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
therapy.
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
tests
- Diabetes, liver, heart, kidney or uncorrected thyroid disease
Type of Study:
Interventional
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:
No
Principal Investigator
Richard Legro, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Milton S. Hershey Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
2003-172
NCT ID:
NCT00151411
Start Date:
October 2004
Completion Date:
March 2008
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic Ovary Syndrome (PCOS)
- Anovulation
- Elevated Testosterone
- Polycystic Ovary Syndrome
Name | Location |
|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
