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RECRUITING
NCT07164183
PHASE3

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

Sponsor: Alcea

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2025-09-11

Completion Date

2026-11

Last Updated

2025-09-18

Healthy Volunteers

No

Conditions

Interventions

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

Locations (8)

Research Site

Kazan', Russia

Research Site

Moscow, Russia

Research Site

Rostov-on-Don, Russia

Research Site

Ryazan, Russia

Research Site

Saint Petersburg, Russia

Research Site

Smolensk, Russia

Research Site

Tver', Russia

Research Site

Yaroslavl, Russia