Clinical Trial: Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

Brief Summary:

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)

Detailed Summary:

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.


Sponsor: University of Rochester

Current Primary Outcome: 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


Original Primary Outcome: recruit adolescent girls with PCOS into a 24 week pilot, randomized clinical trial with four arms- metformin, placebo, oral contraceptives or lifestyle modification [ Time Frame: 24 week ]

Current Secondary Outcome:

  • 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
  • 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.
  • Change in SHBG [ Time Frame: baseline and 24 weeks ]
    Measurement of SHBG by treatment group pre and post intervention
  • 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
  • Change in Fasting Glucose [ Time Frame: baseline and 24 weeks ]
    Change in fasting glucose concentration by treatment group pre to post intervention


Original Secondary Outcome:

  • Assess the effectiveness of the lifestyle management program in producing sustained weight reduction in the overweight adolescent with PCOS [ Time Frame: 24 weeks ]
  • Compare lifestyle management, metformin and placebo with respect to changes in insulin resistance, rates of ovulation and changes intestosterone, sex hormone binding globulin (SHBG), ovarian volume, body composition and lipids [ Time Frame: 24 weeks ]


Information By: University of Rochester

Dates:
Date Received: July 8, 2008
Date Started: August 2002
Date Completion:
Last Updated: April 29, 2015
Last Verified: May 2011