Actively Recruiting
Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
Led by Alcea · Updated on 2025-09-18
290
Participants Needed
8
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides written informed consent according to current laws
- Female aged 18 to 45 years in reproductive/premenopausal period at consent
- Surgically diagnosed with endometriosis within 60 months and at least 2 weeks before study entry, stage I-III
- Has spontaneous, regular menstrual cycles 24-38 days for past 2 cycles and screening period
- No current need for surgical treatment of endometriosis
- Endometriosis-related pelvic pain with average daily VAS score 3.5 cm during 2 months before screening and screening cycle
- Other endometriosis symptoms present (e.g., dysmenorrhea, dyspareunia, dyschezia, imaging findings)
- Agrees to use highly effective contraception from consent through study and 2 months after
- Negative pregnancy test
- Completed daily diary at least 75% of days during screening cycle
You will not qualify if you...
- Contraindications to Indinol Forto (indole-3-carbinol) or Visanne (dienogest)
- Undiagnosed abnormal vaginal or urinary bleeding within 6 months before screening
- Chronic pelvic pain from conditions other than endometriosis
- Chronic non-pelvic pain requiring ongoing therapy
- Endometrioid cysts 3 cm
- History of hysterectomy or bilateral oophorectomy or premature ovarian failure
- Significant gynecologic conditions found at screening (large ovarian cysts, active infections)
- Non-responsive to prior hormonal treatments for endometriosis-related pelvic pain
- History of malignancies within 5 years except certain skin or cervical cancers
- Severe renal failure (GFR <30 ml/min/1.73 m2)
- High blood pressure (systolic >160 mm Hg or diastolic >90 mm Hg)
- Abnormal lab tests beyond protocol limits
- Thyroid dysfunction (TSH <0.4 or >4.0 mU/L)
- Pregnant or lactating
- Other medical conditions or risks per investigator judgment
- History of alcohol or substance abuse
- Participation in another clinical study within 90 days
- Conditions requiring surgery or prohibited therapies during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Research Site
Kazan', Russia
Not Yet Recruiting
2
Research Site
Moscow, Russia
Not Yet Recruiting
3
Research Site
Rostov-on-Don, Russia
Not Yet Recruiting
4
Research Site
Ryazan, Russia
Actively Recruiting
5
Research Site
Saint Petersburg, Russia
Not Yet Recruiting
6
Research Site
Smolensk, Russia
Actively Recruiting
7
Research Site
Tver', Russia
Not Yet Recruiting
8
Research Site
Yaroslavl, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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