Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Polycystic Ovary Syndrome
Interventions
DRUG

Metformin

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

DRUG

Placebo

Placebo

BEHAVIORAL

Lifestyle Intervention

A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.

Trial Locations (1)

17033

Penn State Milton S. Hershey Medical Center, Hershey

All Listed Sponsors
collaborator

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

NIH

lead

Milton S. Hershey Medical Center

OTHER

NCT00151411 - Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS) | Biotech Hunter | Biotech Hunter