Efficacy of estetrol (E4) 15 mg/ drospirenone (DRSP) 3 mg combination for the treatment of dysmenorrhea in women with recurrent endometriosis and/or adenomyosis

OBJECTIVE: To evaluate the efficacy and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg in the treatment of dysmenorrhea associated with recurrent endometriosis and/or adenomyosis. MATERIALS AND METHODS: This retrospective observational study reviewed the medical records of 23 women undergoing E4/DRSP treatment. Among them, 14 patients with recurrent endometriosis and/or adenomyosis who completed at least 16 weeks of treatment were analyzed. The primary outcome was the change in endometriosis-associated pain severity, assessed using a visual analogue scale (VAS). Secondary outcomes included changes in serum estradiol and cancer antigen 125 (CA-125) levels, as well as patient-reported quality of life. Biochemical data were available for 11 patients. Statistical analysis was performed using paired t-tests, with significance defined as p < 0.05. RESULTS: The mean baseline VAS score was 7.7 with 95% confidence interval (CI) 6.9 to 8.6, which decreased significantly to 3.3 (95% CI, 2.3 to 4.3) after treatment (p < 0.005). The average VAS responder rate was 55.8%, with 85.7% of patients achieving a ≥30% reduction and defined as responder. Serum estradiol levels significantly declined (p = 0.024), from 214 pg/ml (95%CI, 34.7-394.1 pg/ml) to 42.7 pg/ml (95% CI, 2.23-83.2 pg/ml), whereas CA-125 showed a nonsignificant downward trend. No serious adverse events occurred. A total of 86% of patients reported improved quality of life. CONCLUSION: The E4/DRSP combination regimen appears to be an effective and well-tolerated treatment for dysmenorrhea in women with recurrent endometriosis and/or adenomyosis. It may serve as a viable long-term hormonal option, for those intolerant or have contraindications to conventional therapies.