ArticleEClinicalMedicine2025
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.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical and endocrine effects of pharmacological therapy in endometriosis: a systematic review and meta-analysis.Frontiers in endocrinology · 2026Pooled it
- MASLD, diabetes and PMOS across the female life stages.Diabetologia · 2026Review
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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 <35 kg/m Findings: Between Nov 2, 2021, and Dec 5, 2023, of 500 patients screened, 305 participants were enrolled and randomised to study groups and 202 participants completed the trial to the end of Cycle 9. The safety set comprised 291 participants (DNG + EE, n = 234; placebo, n = 57) and 256 participants were included in the full analysis set (FAS; DNG + EE, n = 209; placebo, n = 47). 76 (DNG + EE) and 27 (placebo) participants discontinued the trial early, including 18 and four who discontinued due to adverse events; 168 and 34 participants, respectively, completed the trial. Least squares (LS) mean changes from baseline to end of Cycle 9/EDV in adapted mFG score were -3.8 and -1.5 for the DNG + EE and placebo groups, respectively (difference -2.24 ± 0.49 (98.75% CI: -∞, -1.14; p < 0.0001; MMRM, FAS). In the ≤30 and > 30 kg/m Interpretation: Our findings show that oral prolonged-release DNG 2 mg plus EE 0.2 mg in a 24/4-day regimen for up to 9 cycles is an effective treatment for hirsutism in women with PCOS, with an acceptable safety profile. Further research is required to assess DNG + EE in treating hirsutism among different cultural and ethnic populations as well its impact on mood disorders (depression and anxiety) in women with hirsutism-associated PCOS. Funding: Chemo Research S.L.
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