NCT07164183

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

Prospective, Multicenter, Open-label, Randomized, Parallel Groups Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules (LLC Alcea, Russia) and Visanne 2 mg Tablets (BAYER AG, Germany) in Treatment of Endometriosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Alcea · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Prospective open-label randomized parallel groups study to compare efficacy and safety of Indinol Forto® 200 mg capsules and Visanne 2 mg tablets in treatment of endometriosis. This is phase 3 study, based on hypothesis of non-inferiority.

Detailed description

Prospective open-label randomized parallel groups study to compare efficacy and safety of Indinol Forto® 200 mg capsules and Visanne 2 mg tablets in treatment of endometriosis. This is phase 3 study, based on hypothesis of non-inferiority. The study population consists of females from 18 to 45 years old inclusively at the moment of screening who have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within not more than 60 months and not less than 2 weeks of study entry, and reported at least moderate pelvic pain within minimum 2 months of study entry. Study participants are observed during 1 menstrual cycle during screening period (Screening Cycle). Participants who meet inclusion criteria and don't meet exclusion criteria will be randomly assigned to one of two treatment arms (Group 1: Indinol Forto® 200 mg capsules two times per day or Group 2: Visanne 2 mg tablets once per day). After observation on treatment during 24 weeks (monthly Visits 1-7) the study subjects enter post-treatment period and are observed for one more month (Post-Treatment Period, Visit 8). Visual Analog Scale (VAS) is used in the study as the main tool for assessment of daily pelvic pain. Cyclic and non-cyclic pain, as well as intensity of vaginal bleeding are assessed daily during the study. The study primary efficacy endpoint is the change in average daily pelvic pain score (cyclic and non-cyclic, combined) during the 6th treatment period (interval between Visit 6 and Visit 7) in comparison to the Screening period.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Indole-3-carbinol	Indinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks
DRUG	Dienogest	Visanne (dienogest) 2 mg tablets orally once a day during 24 weeks

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2025-09-10
• Last updated: 2025-09-18

Locations

8 sites across 1 country: Russia