Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: yes

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.

Arms:
arm 1: Metformin arm 2: Oral Contraceptive Pills arm 3: lifestyle modification program arm 4: placebo to active metformin arm

Interventions: intervention 1: Metformin intervention 2: Oral Contraceptive Pills (Yasmin) intervention 3: Lifestyle Modification intervention 4: placebo
Intervention descriptions: intervention 1: Metformin 425mg. capsules, 2 capsules BID x 24 weeks intervention 2: Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks intervention 3: weekly classes x 24 weeks for training in diet, exercise and behavior modification skills intervention 4: placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Protocol document: