CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Metformin +8 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00283816
NCT00283816Phase 3Completed
CompareCT.gov

Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)

University of Rochester·interventional·Posted Jan 30, 2006·Updated May 15, 2015

In Brief

A Phase 3 clinical trial evaluating Metformin, Oral Contraceptive Pill, and 7 other interventions for Polycystic Ovary Syndrome. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.4 years ago

Interventions

Metformindrug

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

Oral Contraceptive Pilldrug

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

Lifestyle Management Programbehavioral

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

Quality of Life Questionnairebehavioral

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

Oral Glucose Tolerance Testprocedure

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

Blood workprocedure

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

Abdominal Ultra Soundprocedure

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

Dual-energy x-ray absorptiometry (DEXA scan)procedure

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

placebodrug

placebo capsules, two capsules BID