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

NCT ID: NCT00151411

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-03-31

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.

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

Lifestyle Intervention

Intervention Type: BEHAVIORAL

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Metformin

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048.

Reference Type: DERIVED

PMID: 21704212 (View on PubMed)

Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30.

Reference Type: DERIVED

PMID: 21193187 (View on PubMed)

Related Links

http://www.pennstatehershey.org/web/obgyn/patientcare/clinicaltrials

Click here for more information about this study

Other Identifiers

HD-02-012

Identifier Type: -

Identifier Source: secondary_id

2003-172

Identifier Type: -

Identifier Source: org_study_id