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

Objective: To compare the effectiveness of two different treatment regimens of dydrogesterone in the management of endometriosis-related chronic pelvic pain. Design: Observational, prospective cohort study over six months. Setting: Twenty gynecology clinics in the Russian Federation. Patient(s): Three hundred fifty women from 18 to 45 years of age with endometriosis and chronic pelvic pain with or without dysmenorrhea. Intervention(s): 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. Main Outcome Measure(s): Intensity of chronic pelvic pain on the 11-point numerical rating scale (after 6 months). Result(s): 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. Conclusion(s): 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. Registration Number: NCT03690765. © 2021 The Authors

Authors
Sukhikh G.T.1 , Adamyan L.V.1, 2 , Dubrovina S.O.3 , Baranov I.I.1 , Bezhenar V.F.4 , Kozachenko A.V.1 , Radzinsky V.E. 5 , Orazov M.R. 5 , Yarmolinskaya M.I.6, 7 , Olofsson J.I.8, 9
Publisher
Elsevier Inc.
Number of issue
6
Language
English
Pages
1568-1577
Status
Published
Volume
116
Year
2021
Organizations
  • 1 National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russian Federation
  • 2 Department of Obstetrics and Gynecology, First Moscow State Medical University, Moscow, Russian Federation
  • 3 Scientific Research Institute of Obstetrics and Pediatrics, Rostov State Medical University, Rostov-on-Don, Russian Federation
  • 4 Department of Obstetrics and Neonatology, Department of Obstetrics, Gynecology and Reproduction, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
  • 5 Department of Obstetrics and Gynecology, Medical Institute of Peoples’ Friendship University of Russia, Ministry of Education of Russia, Moscow, Russian Federation
  • 6 Department of Gynecology and Endocrinology, Scientific Research Institute of Obstetrics, Gynecology and Reproduction named after D.O. Ott, Saint Petersburg, Russian Federation, Russian Federation
  • 7 Department of Obstetrics and Gynecology, North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russian Federation
  • 8 Global Medical Affairs, Established Pharmaceuticals Division, Abbott Product Operations AG, Allschwil, Switzerland
  • 9 Division of Obstetrics and Gynecology, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
Keywords
Dydrogesterone; dysmenorrhea; endometriosis; pelvic pain; progestogens
Date of creation
16.12.2021
Date of change
16.12.2021
Short link
https://repository.rudn.ru/en/records/article/record/76476/
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