drugset / Trial / NCT00283816

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

NCT00283816

Phase 3 Completed 36 enrolled University of Rochester
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-01
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg
Comparator drospirenone Unknown Oral
Comparator ethinyl estradiol Small molecule Oral