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

Phase 2 Completed 114 enrolled Milton S. Hershey Medical Center Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

Timeline

Start: 2004-10
Primary completion: 2008-03
Completion: 2008-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Metformin vs Placebo; p = 0.54; Mean Difference (Final Values) 4.3 (95% CI -9.9 to 18.4); Mixed Models Analysis NCT00151411 ↗

Publications

Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Lee PA, Williams NI, Coney P, Legro RS. Effects of metformin in adolescents with polycystic ovary syndrome undertaking lifestyle therapy: a pilot randomized double-blind study. Fertil Steril. 2011 Jun 30;95(8):2595-8.e1-6. doi: 10.1016/j.fertnstert.2011.05.048.
Ladson G, Dodson WC, Sweet SD, Archibong AE, Kunselman AR, Demers LM, Williams NI, Coney P, Legro RS. The effects of metformin with lifestyle therapy in polycystic ovary syndrome: a randomized double-blind study. Fertil Steril. 2011 Mar 1;95(3):1059-66.e1-7. doi: 10.1016/j.fertnstert.2010.12.002. Epub 2010 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	2000 mg	—