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

This study has been completed.
Sponsor:
Collaborator:
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
ClinicalTrials.gov Identifier:
NCT00151411
First received: September 8, 2005
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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
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
Placebo
 Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   12 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151411

Locations
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)
Investigators
Principal Investigator: Richard Legro, M.D. Milton S. Hershey Medical Center
  More Information

Additional Information:
Click here for more information about this study  This link exits the ClinicalTrials.gov site

No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov 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)
Anovulation
Elevated Testosterone

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013