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.
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 classification of American Fertility Society (R-AFS, 1985)).
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.
Presence of contraindications to Indinol Forto (indolcarbinol)
Presence of contraindications to Visanne (dienogest)
Participant had undiagnosed (unexplained), abnormal, vaginal or urinary tract bleeding within the past 6 months before screening (Visit 0).
Participant has chronic pelvic pain not caused by endometriosis, but other gynecological or urological disorders (consequences of inflammatory process, uterine fibroids, pelvic congestion syndrome, etc.).
Parallel
Indole-3-carbinol
DrugIndinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks
Dienogest
DrugVisanne (dienogest) 2 mg tablets orally once a day during 24 weeks
Average daily pelvic pain score, combined
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.
Average daily pelvic pain score, cyclic
Change in average daily VAS (in mm) endometriosis-related pelvic pain score (cyclic) during Treatment Periods in comparison to Screening Cycle as reported in the participant's diary.
Average daily pelvic pain score, non-cyclic
Change in average daily VAS (mm) endometriosis-related pelvic pain score (non-cyclic) during Treatment Periods in comparison to Screening Cycle as reported in the participant's diary.
Proportion of participants with improvement
Proportion of participants with more than 10 mm reduction (at least minimal clinically significant change) in average daily pelvic pain score (cyclic, non-cyclic and combined) during Treatment Period 6 (assessed at Visit 7) in comparison to Screening Cycle
Change in signs and symptoms of endometriosis assessed in B&B scale
Change in signs and symptoms of endometriosis (including dyspareunia), assessed with B\&B scale at visits 2, 4, 7, 8 in comparison to baseline (Visit 1).
Estrogens level
Proportion of subjects with minimum 5% decrease of estrogens (estrone and estradiol) level.
Estrogens index
Proportion of subjects with minimum 5% increase of estrogens (estrone/estradiol) metabolic index.
Ferritin level
Proportion of subjects with ferritin below 20 ng/ml at Visit 0 and at Visit 7.
