Prolonged cyclical and continuous regimens of dydrogesterone are effective for reducing chronic pelvic pain in women with endometriosis: results of the ORCHIDEA study

To compare the effectiveness of two different treatment regimens of dydrogesterone in the management of endometriosis-related chronic pelvic pain. Observational, prospective cohort study over six months. Twenty gynecology clinics in the Russian Federation. Three hundred fifty women from 18 to 45 years of age with endometriosis and chronic pelvic pain with or without dysmenorrhea. Dydrogesterone 10 mg 2 or 3 times daily, either between the 5th and 25th days of the menstrual cycle (prolonged cyclical treatment regimen) or continuously (continuous treatment regimen). For all patients, the data cutoff was at six months of treatment. Intensity of chronic pelvic pain on the 11-point numerical rating scale (after 6 months). A marked reduction in chronic pelvic pain was observed with both the prolonged cyclical and continuous treatment regimens (mean ± standard deviation change from baseline –3.3 ± 2.2 and –3.0 ± 2.2, respectively), with no significant difference between the two groups. With both regimens, patients experienced significant improvements in the intensity of chronic pelvic pain, number of days in which analgesics were required, severity of dysmenorrhea, sexual well-being, and health-related quality-of-life parameters. A favorable safety profile of dydrogesterone was confirmed, and no serious adverse drug reactions were reported during the study. Prolonged cyclical and continuous treatment regimens of dydrogesterone therapy both demonstrated a pronounced and similar reduction in the severity of chronic pelvic pain and dysmenorrhea and led to marked improvements in all study parameters related to quality of life and sexual well-being. NCT03690765. Los regímenes de tratamiento de didrogesterona cíclicos y continuos prolongados son efectivos para reducir el dolor pélvico crónico en mujeres con endometriosis: resultados del estudio ORCHIDEA. Comparar la efectividad de dos regímenes de tratamiento diferentes de didrogesterona en el manejo de dolor pélvico crónico relacionado con la endometriosis. Estudio de cohortes prospectivo observacional durante seis meses. Veinte clínicas ginecológicas en la Federación Rusa. Trescientas cincuenta mujeres entre 18 y 45 años de edad con endometriosis y dolor pélvico crónico con o sin dismenorrea. Didrogesterona 10 mg 2 ó 3 veces al día, bien entre los días 5 y 25 del ciclo menestrual (régimen de tratamiento cíclico prolongado) o ininterrumpido (régimen de tratamiento continuo). Para todas las pacientes se limitó al recog