Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
In plain words A Phase 3 study of indole-3-carbinol in female participants 18 to 45, run by Alcea. It plans to enroll about 290 people at 8 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 45. Conditions: Endometriosis.
- The participant provides written informed consent for participation in the study in accordance with current legislation.
- Female participants in reproductive/premenopausal period from 18 to 45 years old inclusively (at the moment of signing informed consent).
- Participants have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis (ICD code #80) within not more than 60 months and not less than 2 weeks of study entry, stage I-III according to endometriosis revised…
- Participant has had spontaneous, (i.e., without hormonal therapy) regular, menstrual cycles with a cycle length between 24 to 38 days (inclusive) for the past 2 cycles before Visit 0 and during screening period.
6 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Indole-3-carbinol; Dienogest
Registered 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.
Where, as registered
No US site; Russia (8).