SAT-133 Addition of Metformin Does Not Alter Metabolic Impact of Combined Oral Contraceptive Pills in Hyperandrogenic Women with Polycystic Ovary Syndrome: Findings from COMET-PCOS Trial
Abstract
Abstract Disclosure: C.M. Stetter: None. W.C. Dodson: None. C. Coutifaris: None. OBJECTIVE: Combined oral contraceptive pills (COCPs) are used as first-line treatment for polycystic ovary syndrome (PCOS), which is associated with increased cardiovascular disease (CVD) risk even at a young age. Some studies suggest a detrimental effect of COCPs on metabolic parameters, but their impact in women with a hyperandrogenic phenotype who are overweight or obese remains controversial. Moreover, it is unclear if use of Metformin alone or in combination with COCPs alters this impact. This study aimed to compare the effect of COCPs, Metformin, and COCP+Metformin on metabolic parameters. MATERIALS AND METHODS: This was a double-blind, placebo-controlled randomized clinical trial performed at 2 U.S. sites. 240 women with hyperandrogenic PCOS and BMI ≥25kg/m2 were randomized to 6 months of continuous COCPs (20ug ethinyl estradiol/0.15mg desogestrel) (n=79), extended-release 2000mg/day Metformin (n=81), or a combination (COCP+Metformin) (n=80). Outcomes included changes from baseline in 2-hour oral glucose tolerance test (GTT) results, waist circumference (WC), android fat mass on DEXA scan, and lipoproteins using NMR. Linear mixed models were fit to assess differences between treatment arms with respect to changes from the start to end of the study. RESULTS: Mean age was 29.5±5.2 years, and mean BMI was 35.6±5.7kg/m2. 24% identified as Black. In the COCP and COCP+Metformin arms, mean BMI…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 240 participants or records.
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