RecruitingPhase 3NCT07164183

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


Sponsor

Alcea

Enrollment

290 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dienogest and a drug called Indole-3-carbinol for people with endometriosis. The study is currently recruiting participants at 8 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndole-3-carbinol

Indinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks

DRUGDienogest

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

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NCT07164183


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