A randomized, double‐blind, placebo‐controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis
Abolfazl Mehdizadeh Kashi, Gelareh Niakan, Majid Ebrahimpour, Leila Allahqoli, Babak Hassanlouei, Georgios Gitas, İbrahim Alkatout
Abstract
OBJECTIVE: To compare the effects of dienogest and a combined oral contraceptive pill (COCP) after laparoscopic surgery on pain and quality of life in women with severe endometriosis. METHODS: A randomized double-blind pilot study was conducted from March 2018 to March 2020 in women with severe endometriosis confirmed by laparoscopic surgery. A total of 108 patients who had undergone laparoscopic surgery received dienogest, COCP, or placebo daily for 6 months. Primary and secondary outcomes were compared between the three groups. RESULTS: Treatment with dienogest or COCP was associated with improved self-reported pain after 6 months of treatment, as evidenced by significantly lower scores for pelvic pain and dyspareunia compared with placebo (P < 0.05). Significant differences in overall quality of life score were observed over 6 months in the dienogest, COCP, and placebo groups (mean difference 22.00, 23.45, and 6.45 points, respectively; P < 0.001). Post-hoc analysis revealed a significant difference in overall quality of life score between the placebo group and the dienogest (P < 0.001) and COCP groups (P = 0.004). CONCLUSION: Postoperative administration of dienogest or COCP reduced endometriosis-associated pain and improved quality of life in women with severe endometriosis. CLINICAL TRIALS REGISTRATION: https://en.irct.ir/trial/43070.