Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

Summary

Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.

Conditions

• Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

Metformin 500 mg. tabs 2 tabs BID for duration of study

DRUG

Oral Contraceptive Pill

Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study

BEHAVIORAL

Lifestyle Management Program

Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise \& behavior modification skills on a regular weekly basis over the 24 week study

BEHAVIORAL

Quality of Life Questionnaire

Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion

PROCEDURE

Oral Glucose Tolerance Test

Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion

PROCEDURE

Blood work

Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.

PROCEDURE

Abdominal Ultra Sound

transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion

PROCEDURE

Dual-energy x-ray absorptiometry (DEXA scan)

Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion

DRUG

placebo

placebo capsules, two capsules BID

Sponsors & Collaborators

• University of Rochester

  lead OTHER

Principal Investigators

• Kathleen Hoeger, MD · University of Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2008-01-31

Completion

2008-01-31

Countries

• United States

Study Locations