Comparing the Effects of Oral Contraceptive Pills Versus Metformin

Phase 3 Completed 240 enrolled Anuja Dokras Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab Milton S. Hershey Medical Center · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

To determine the effect of Oral Contraceptive Pills (OCP) verses Metformin verses OCP and Metformin on the prevalence of Metabolic Syndrome (MetS) and its components in overweight/obese women with Polycystic Ovary Syndrome (PCOS). The combination of OCP and metformin (OCP, through lowering androgens, and metformin, through improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the risk profile for the development of diabetes and possible cardiovascular disease (CVD) in young women with PCOS.

Timeline

Start: 2018-01-15
Primary completion: 2024-01-23
Completion: 2024-07-15

Publications

Dokras A, Coutifaris C, Remaley AT, Mehta NN, Playford MP, Kunselman AR, Stetter CC, Dodson WC, Legro RS. Impact of combined hormonal contraceptives and metformin on metabolic syndrome in women with hyperandrogenic polycystic ovary syndrome and obesity: The COMET-PCOS randomized clinical trial. PLoS Med. 2025 Dec 8;22(12):e1004662. doi: 10.1371/journal.pmed.1004662. eCollection 2025 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desogestrel	Small molecule	0.15 mg	Oral
Subject	Metformin	Small molecule	2000 mg	Oral
Subject	ethinyl estradiol	Small molecule	20 ug	Oral

Comparing the Effects of Oral Contraceptive Pills Versus Metformin

Summary

Timeline

Publications

Drugs

Indications