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

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ClinicalTrials.gov Identifier: NCT00151411
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : November 8, 2011
Last Update Posted : October 16, 2017
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

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Behavioral: Lifestyle Intervention Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Study Start Date : October 2004
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).
Behavioral: Lifestyle Intervention
A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Behavioral: Lifestyle Intervention
A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.



Primary Outcome Measures :
  1. Change in Testosterone After 6 Months of Treatment [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures :
  1. Ovulation Rate [ Time Frame: 6 months ]
    Ovulation is defined as a binary outcome; ovulated at least once vs. did not ovulate during the treatment period.

  2. Change in Insulin Sensitivity Index After 6 Months of Treatment [ Time Frame: baseline and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 39 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: September 9, 2005    Key Record Dates
Results First Posted: November 8, 2011
Last Update Posted: October 16, 2017
Last Verified: September 2017

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome (PCOS)
Anovulation
Elevated Testosterone

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