Comparing the Effects of Oral Contraceptive Pills Versus Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

January 23, 2024

Study Completion Date

July 15, 2024

Conditions
PCOS
Interventions
DRUG

OCP + Metformin

This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.

DRUG

OCP + Placebo

This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.

DRUG

Metformin + Placebo

This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.

Trial Locations (2)

17033

Penn State/ Hershey Medical Center, Hershey

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Milton S. Hershey Medical Center

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Anuja Dokras

OTHER

NCT03229057 - Comparing the Effects of Oral Contraceptive Pills Versus Metformin | Biotech Hunter | Biotech Hunter