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Indole-3-carbinol

Phase 3

Endometriosis | Small molecule | Other |Bayer AG|Last Updated: Sep 18, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment290

FDA Designations

No designations recorded

Clinical trial landscape

Indole-3-carbinol · 1 trial · 1 indication

Phase 3 1
NCT07164183Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of EndometriosisEndometriosis
RECRUITING290 Analytics
PHASE3RECRUITING
Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Average daily pelvic pain score, combined
Visit 7 (week 24)

Change in average daily VAS (in mm) endometriosis-related pelvic pain score (cyclic and non-cyclic, combined) during Treatment Period 6 (assessed at Visit 7) in comparison to Screening Cycle as reported in the participant's diary.

Secondary Endpoints

Average daily pelvic pain score, cyclic
Visit 7 (week 24)
Average daily pelvic pain score, non-cyclic
Visit 7 (week 24)
Proportion of participants with improvement
Visit 7 (week 24)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALParticipants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks
Arm 2ACTIVE_COMPARATORParticipants receive Visanne 2 mg tablets orally once a day during 24 weeks

Interventions

NameTypeDescription
Indole-3-carbinolDRUGIndinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks
DienogestDRUGVisanne (dienogest) 2 mg tablets orally once a day during 24 weeks
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. The participant provides written informed consent for participation in the study in accordance with current legislation. 2. Female participants in reproductive/premenopausal period from 18 to 45 years old inclusively (at the moment of signing informed consent). 3. Participant...

Countries:Russia
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