Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

Penn State Health

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Placebo; Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00151411

HD-02-012

2003-172

Details and patient eligibility

About

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

Full description

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.

Enrollment: 114 patients

Sex: Female

Ages: 12 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

114 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin

Treatment:

Behavioral: Lifestyle Intervention

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Behavioral: Lifestyle Intervention

Drug: Placebo