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

Sponsor
Alcea
Study ID
NCT07164183
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 10, 2025
Start date
Sep 11, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks
  • Active Comparator: Arm 2
    Participants receive Visanne 2 mg tablets orally once a day during 24 weeks

Primary Outcome Measure

Average daily pelvic pain score, combined [ Time Frame: Visit 7 (week 24) ]

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