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Completed

NCT Number: NCT00151411

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Anovulation Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

12 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Placebo

Drug

Placebo

Lifestyle Intervention

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.

Primary outcomes

  1. Change in Testosterone After 6 Months of Treatment

    Time frame: baseline and 6 months

Secondary outcomes

  1. Ovulation Rate

    Time frame: 6 months

    Count of ovulations per subject during the treatment period.

  2. Change in Insulin Sensitivity Index After 6 Months of Treatment

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

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

Registry information

Official study title

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2005
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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