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

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

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

Trial Locations (1)

14642

University of Rochester Medical Center, Rochester

All Listed Sponsors
lead

University of Rochester

OTHER

NCT00283816 - Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy | Biotech Hunter | Biotech Hunter