Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

University of Rochester

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00714233

RSRB # 09354

Details and patient eligibility

About

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)

Full 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.

Enrollment: 43 patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Metformin

Treatment:

Drug: Metformin

2

Experimental group

Description:

Oral Contraceptive Pills

Treatment:

Drug: Oral Contraceptive Pills (Yasmin)

3

Active Comparator group

Description:

lifestyle modification program

Treatment:

Behavioral: Lifestyle Modification

4

Placebo Comparator group

Description:

placebo to active metformin arm

Treatment:

Drug: placebo