Triptorelin for the treatment of adenomyosis: A multicenter observational study of 465 women in Russia

Objective To evaluate the effectiveness of triptorelin for the treatment of adenomyosis, the benign invasion of endometrial tissue into the myometrium, as a fertility-preserving alternative to the gold standard hysterectomy. Methods In this multicenter, open-label, observational study in Russia, performed from November 3, 2011, to August 24, 2015, we assessed the efficacy and safety of triptorelin 3.75 mg administered intramuscularly every 28 days in Russian women who were gonadotropin-releasing hormone agonist treatment-naive, aged 25-40 years, and had a diagnosis of endometriosis or adenomyosis with heavy menstrual bleeding. We performed a medical record review, interviews to assess symptom severity, and pelvic assessments including transvaginal ultrasound. Data were obtained at first injection of triptorelin (visit 1), on the day of last injection (visit 2), 6 months after last injection (visit 3), and 9 months after last injection (visit 4). Significance was assessed by Wilcoxon signed rank test. Results A total of 465 women were included. There was a significant improvement from baseline in severity of heavy menstrual bleeding in 390/463 (84.2%) of women 6 months after last injection (P<0.0001). Severity of dysmenorrhea, abnormal uterine bleeding, and pelvic pain was decreased at visit 3 compared with baseline (P<0.0001). Endometriosis symptoms stopped in 253/262 (96.6%) of women at visit 2 and in 243/263 (92.4%) of women at visit 3. Pregnancy was reported in 116/465 (24.9%) women within 9 months following the end of treatment. Conclusion Triptorelin has a favorable safety profile, is highly efficacious in treating clinical symptoms of adenomyosis, and improves reproductive function. ClinicalTrials.gov registration number: A-38-52014-191, registered October 2011.