Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT00714233

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2007-12-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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

2

Oral Contraceptive Pills

Group Type: EXPERIMENTAL

Oral Contraceptive Pills (Yasmin)

Intervention Type: DRUG

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

3

lifestyle modification program

Group Type: ACTIVE_COMPARATOR

Lifestyle Modification

Intervention Type: BEHAVIORAL

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

4

placebo to active metformin arm

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

Metformin

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

Intervention Type: DRUG

Oral Contraceptive Pills (Yasmin)

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

Intervention Type: DRUG

Lifestyle Modification

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

Intervention Type: BEHAVIORAL

placebo

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

Intervention Type: DRUG

Other Intervention Names

Yasmin oral COntraceptive tabs; pharmacy matched placebo capsules

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kathleen M. Hoeger, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen M Hoeger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Other Identifiers

RSRB # 09354

Identifier Type: -

Identifier Source: org_study_id