Oral prolonged-release dienogest 2 mg and ethinylestradiol 0.02 mg in a 24/4-day regimen for polycystic ovary syndrome-associated hirsutism: a double-blind, randomised, placebo-controlled trial
Abstract
Background: Current guidelines for polycystic ovary syndrome (PCOS) recommend combined oral hormonal contraceptives as first-line pharmacological treatment to reduce androgen excess and to treat clinical hyperandrogenic skin manifestations, such as hirsutism. However, these are used off-label. We aimed to demonstrate the efficacy of a prolonged-release oral formulation in a 24/4-day regimen for up to nine 28-day consecutive cycles compared with placebo for the clinical management of hirsutism in women with PCOS.
Methods: This was a multinational, multicentre, double-blind, placebo-controlled trial done across 46 sites in Czech Republic, Hungary, Lithuania, Poland, Serbia, Slovakia, Spain and Ukraine. Eligible participants were 2-year-post-menarche women (14-40 years old) with a body mass index (BMI) of 18 to 2 who were diagnosed with clinical hyperandrogenism (adapted modified Ferriman-Gallwey [mFG] score ≥7) plus oligomenorrhea of ≤6 menses per year and/or polycystic ovary morphology. Enrolled participants were randomised (4:1) to prolonged-release once-daily oral dienogest 2 mg (DNG) + ethinylestradiol 0.02 mg (EE) in a 24/4-day regimen (DNG + EE group) or placebo for up to nine 28-day cycles. Co-primary endpoints were: (1) the change from baseline in the adapted mFG score at the end of Cycle 9 or at the early discontinuation visit (EDV), and (2) proportion of responders, defined as participants with an adapted mFG score reduction of 50% from baseline to the end of Cycle…
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: 305 participants or records.
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