Phase 3 Study Comparing Indinol Forto 200 mg Capsules and Visanne 2 mg Tablets for Treating Endometriosis in Women Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Indinol Forto 200 mg capsules compared to Visanne 2 mg tablets for treating endometriosis in females aged 18 to 45. This phase 3, open-label, randomized study is designed to test whether Indinol Forto is not less effective than Visanne. Participants have endometriosis confirmed by surgery within the past 60 months and experience moderate pelvic pain. Participants will be randomly assigned to one of two groups one group will take Indinol Forto capsules twice daily, and the other group will take Visanne tablets once daily, both for 24 weeks. Before treatment starts, there is a screening menstrual cycle to confirm eligibility. After completing the 24-week treatment period, participants will be observed for an additional month during a post-treatment follow-up. During the study, participants will daily record pelvic pain using a Visual Analog Scale, noting both cyclic and non-cyclic pain and vaginal bleeding intensity. Researchers will assess changes in average daily pelvic pain after 24 weeks of treatment compared to the screening period. Additional evaluations include quality of life, endometriosis symptoms, menstruation patterns, and lesion size. Safety and symptom changes will be monitored throughout the study and post-treatment period.

Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis