The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as Spironolactone) to not only prevent chronic anovulation but also suppress elevated testosterone levels and its clinical effects on the body. While there are multiple OCPs available on the market today and several studies that look at different progestins and their anti-androgenicity, not much is known about whether the length of active pills in OCP therapy (3 weeks versus 6 months) has any further benefit in continued suppression of testosterone and subsequently improvement in clinical findings of hyperandrogenism in the PCOS population. In this pilot randomized open label clinical trial, females between the ages of 16 and 35 years diagnosed with PCOS based on the Rotterdam Criteria, and not currently on medical therapy with an OCP will be enrolled in the study and randomized to either a continuous 6 month OCP or cyclical 21 day active OCP therapy. Our aim is to conduct a pilot randomized clinical trial to determine the effect of 6 months of active monophasic OCPs on testosterone levels and cutaneous findings of hyperandrogenism (hirsutism and acne) as compared to a traditional 21 day active/7 day placebo OCP in women with PCOS. These findings will be compared over a 6 month period.
Age range
15 Years – 40 Years
Sex
FEMALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation
Timeframe: measured at baseline and 1 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation
Timeframe: measured at baseline and 3 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation
Timeframe: measured at baseline and 6 month into therapy