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Effect of an oral androgen (dehydroepiandrosterone) on hepatic globulins in users of an antiandrogenic combined oral contraceptive (ethinyl estradiol/drospirenone)

Bethany Waites, BA, Oregon Health and Science University

Venous thromboembolism (VTE) events pose a significant health risk for women who use combined oral contraceptives (COCs). COCs are composed of an estrogen (most commonly ethinyl estradiol) and a synthetic progestogen (progestin). The dose-dependent relationship between estrogen exposure and VTE risk is well studied, and is due to changes in hepatic globulins mediated by activity at hepatic estrogen receptors. In contrast, the mechanism by which progestins impact VTE risk is unclear, and because there are no hepatic progesterone receptors, progestin's impact on coagulation proteins must be mediated by another pathway. Interestingly, studies suggest that VTE risk varies between users of COCs with more or less androgenic progestins. Our proposal is designed to address the role of androgen receptor activity in VTE risk. We hypothesize that supplemental androgen in the form of dehydroepiandrosterone (DHEA) will counteract the estrogen-mediated changes in hepatic globulins measured in women taking COCs containing ethinyl estradiol in combination with the antiandrogenic progestin (drospirenone, DRSP). We will enroll a total of 20 women who are current users of ethinyl estradiol/drospirenone COCs and use a randomized permuted block algorithm to allocate participants to either a daily DHEA supplement or placebo. Data will be analyzed using intention-to-treat and per-protocol approaches. For each outcome, we will compare the difference in change from baseline between study groups (DHEA vs placebo) using two-sample t-tests.

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