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Completed

NCT Number: NCT00714233

Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood)

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Menstruation Disturbances Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.

Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Menstrual irregularity defined as cycle length > 45 days
  • Overweight as BMI > 25
  • Clinical evidence of hirsuitism or acne
  • Testosterone > 50ng/dL

Exclusion criteria

  • History of diabetes mellitus
  • History of Cushing's disease
  • History of hyperprolactinemia
  • Untreated hypo or hyperthyroidism
  • History of adrenal hyperplasia
  • Significant renal impairment
  • Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
  • Exercise > 10 hours per week

Treatment and study plan

metformin

Drug

Metformin 425mg. capsules, 2 capsules BID x 24 weeks

Oral Contraceptive Pills (Yasmin)

Drug

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

Other names: Yasmin oral COntraceptive tabs

Lifestyle Modification

Behavioral

weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

Placebo

Drug

placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Other names: pharmacy matched placebo capsules

Primary outcomes

  1. Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

    Time frame: 24 week

    The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY

Secondary outcomes

  1. Weight Loss in Lifestyle Intervention Group

    Time frame: baseline and 24 weeks

    In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI

  2. Change in Free Androgen Index (FAI)

    Time frame: baseline and 24 weeks

    Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.

  3. Change in SHBG

    Time frame: baseline and 24 weeks

    Measurement of SHBG by treatment group pre and post intervention

  4. Triglyceride Concentration by Treatment Group

    Time frame: baseline and 24 weeks

    Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo

  5. Change in Fasting Glucose

    Time frame: baseline and 24 weeks

    Change in fasting glucose concentration by treatment group pre to post intervention

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Important dates

Study start
2002
Primary completion
2004
Study completion
2007
First posted
Jul 14, 2008
Registry last updated
May 15, 2015

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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