Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Phase 3

Completed

Interventions: Behavioral: Lifestyle Modification
Drug: placebo
Drug: Oral Contraceptive Pills (Yasmin)
Drug: Metformin

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 Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
3	Lifestyle Modification	lifestyle modification program
4	placebo	placebo to active metformin arm
2	Oral Contraceptive Pills (Yasmin)	Oral Contraceptive Pills
1	Metformin	Metformin

Primary Outcome Measures

Name	Time	Method
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification	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 Outcome Measures

Name	Time	Method
Weight Loss in Lifestyle Intervention Group	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 Fasting Glucose	baseline and 24 weeks	Change in fasting glucose concentration by treatment group pre to post intervention
Change in Free Androgen Index (FAI)	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	baseline and 24 weeks	Measurement of SHBG by treatment group pre and post intervention
Triglyceride Concentration by Treatment Group	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