Effectiveness and safety of dydrogesterone versus dienogest after laparoscopic cystectomy for ovarian endometrioma: a multicenter prospective cohort study
Year: 2026
Type: preprint
Abstract: Background Prospective evidence to guide the choice between dydrogesterone and dienogest after laparoscopic cystectomy for ovarian endometrioma remains limited. This study compared their effectiveness and safety in women of reproductive age to inform individualized postoperative treatment. Methods This prospective multicenter cohort enrolled women aged 18–45 years who underwent laparoscopic cystectomy for histologically confirmed ovarian endometrioma at four hospitals in Guangdong Province, China. Patients and clinicians jointly selected postoperative therapy with either dydrogesterone (10 mg twice daily on cycle days 5–25) or continuous dienogest (2 mg daily) during routine care. The primary outcome was the change in visual analog scale (VAS) pain score from preoperative baseline to week 24. Between-group differences were estimated using covariate-adjusted analysis of covariance with HC3 robust standard errors. The study was registered at ClinicalTrials.gov (NCT05976529) on 25 April 2023. Results A total of 242 women were enrolled: 109 initiated dydrogesterone and 133 initiated dienogest; 234 (96.7%) had VAS data available at week 24. The adjusted between-group difference in VAS pain score change was 0.00 points (95% CI, − 0.44 to 0.43; P = 0.983; dydrogesterone minus dienogest), and estimates were similar across sensitivity analyses. At week 24, the improvement in the Mental Component Summary score of the 12-Item Short Form Health Survey was greater with dydrogesterone (adjusted mean difference, 5.32 points; 95% CI, 2.28 to 8.35; Benjamini-Hochberg [BH]-adjusted P = 0.004). Cyclic bleeding was the predominant bleeding pattern in the dydrogesterone group, whereas no bleeding was the predominant pattern in the dienogest group. Through week 24, any adverse event was reported in 38.1% of the dydrogesterone group versus 54.3% of the dienogest group (BH-adjusted P = 0.063); anxiety or depression (5.7% vs 22.5%; BH-adjusted P = 0.009) and insomnia (4.8% vs 17.8%; BH-adjusted P = 0.018) were reported less frequently with dydrogesterone than with dienogest. Conclusions After adjustment, the improvement in VAS pain score at 24 weeks did not differ significantly between dydrogesterone and dienogest. Differences in mental well-being, adverse events, and bleeding patterns may help guide individualized postoperative treatment decisions.
Source: Research Square
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225893059
Cites:
Cited by:
Related to: