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

This study has been completed.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center Identifier:
First received: September 8, 2005
Last updated: December 20, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Resource links provided by NLM:

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change in Testosterone After 6 Months of Treatment [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy.

Secondary Outcome Measures:
  • The Investigators Hypothesize That Combination Therapy Will Result in a Greater Improvement in Ovulatory Frequency and Insulin Sensitivity That Single Agent Therapy. [ Time Frame: baseline and monthly, up to six months post-randomization ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: October 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Drug: Metformin
Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
Placebo Comparator: Placebo
Drug: Placebo

Detailed 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.

Ages Eligible for Study:   12 Years to 39 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00151411

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Richard Legro, M.D. Milton S. Hershey Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center Identifier: NCT00151411     History of Changes
Other Study ID Numbers: 2003-172  HD-02-012 
Study First Received: September 8, 2005
Results First Received: June 7, 2011
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome (PCOS)
Elevated Testosterone

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 27, 2016