Study Comparing Implantable Gestrinone Pellets and Oral Dienogest for Treating Endometriosis in Women Aged 18 to 45

What this Trial Is About

Researchers are evaluating the effects of implantable Gestrinone compared to oral Dienogest in adult female patients aged 18 to 45 years with endometriosis. This randomized controlled trial aims to relieve symptoms related to endometriosis, such as dysmenorrhea, dyspareunia, and non-cyclical pelvic pain, while assessing quality of life and sexual function. The study is conducted across private medical clinics in multiple cities and includes 70 participants divided equally into two groups. One group will receive implantable Gestrinone pellets subcutaneously in the gluteal region, dosed at 1.6 mgkg of body weight, with a second implantation at 6 months to evaluate effects over 12 months. The other group will take oral Dienogest at 2 mg daily for 12 months. Both treatments will be monitored through scheduled follow-up visits at 1 week, and 1, 3, 6, 9, and 12 months after starting therapy. Participants will undergo assessments of pain severity using verbal and visual scales, uterine bleeding levels, systemic effects by blood tests, endometrial thickness by ultrasound, body composition, and sexual function questionnaires. Researchers will also evaluate endometriosis lesions and quality of life over the study period. Data analysis will include comparisons between groups and repeated measures over time, with safety and adverse effects monitored throughout the trial.

Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis