Status:
RECRUITING
Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
Lead Sponsor:
Alcea
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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, ...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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.
- Participant has no current indications for surgical treatment of endometriosis.
- Participant has had endometriosis-related pelvic pain assessed with visual analogue scale (VAS) and defined as average daily pain score ≥3.5 cm during 2 menstrual cycles prior to screening (assessed by the participant retrospectively at the moment of screening) and during screening menstrual cycle (according to the data from the participant's diary completed daily).
- Presence of other symptoms of endometriosis (e.g. dysmenorrhea, dyspareunia, dyschezia, data of ultrasound imaging, or magnetic resonance imaging (MRI).
- The participant agrees to use highly effective contraception methods described in the protocol from the time of signing informed consent through the whole duration of the study and for 2 months after the study completion.
- Negative pregnancy test.
- Participant completed daily diary on minimum 75% of days during screening menstrual cycle.
Exclusion
- 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.).
- Participant has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, fibromyalgia, chronic back pain or chronic headaches).
- Endometrioid cysts ≥ 3 cm.
- Participant has a surgical history of hysterectomy and/or bilateral oophorectomy; premature ovarian failure. Note: Participants who have undergone surgical sterilization (eg, bilateral salpingectomy, tubal ligation) are permitted in the trial.
- Participant has a clinically significant gynecologic condition identified in the screening evaluation including, but not limited to, ovarian cysts larger than 3 cm and present longer than 4 months, an active sexually transmitted disease, etc. Note: Participants may be rescreened after completing treatment for infection or for simple ovarian cysts.
- Participant with endometriosis-related pelvic pain who didn't respond to previous treatment with combined oral contraceptives, GnRH agonists or antagonist, progestins or aromatase inhibitors. Note: Participants who demonstrated partial response or interrupted their treatment due to side effects, may be enrolled in the study.
- History of malignancy, including suspected malignization of endometriomas within ≤5 years before signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Severe renal failure (glomerular filtration rate calculated with Cockcroft-Gault formula is below 30 ml/min/1,73 m2).
- Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>90 mm Hg during screening period.
- Clinically significantly abnormal laboratory tests at Screening, including: alkaline phosphatase (AP), alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT) \>200% of the upper limit of normal, or total bilirubin \>150% of the upper limit of normal; hemoglobin \<10 g/dl, white blood cell count \<2500 in mm³, neutrophil count \<1500 in mm³, platelet count \<100 х 10³/mm³.
- Hyperthyroidism (TSH below 0.4 mU/L) or hypothyroidism (TSH above 4.0 mU/L).
- Positive pregnancy test (including pregnancy within 3 months prior to screening) or lactation period.
- Other medical conditions that, in the judgment of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
- History of alcohol or substance abuse.
- Participation in a clinical study within 90 days before screening.
- Other reasons that, in the judgment of the Investigator, may interfere with participation in the study or may lead to unreasonable risks.
- Conditions requiring surgery in the period of the study.
- Conditions requiring therapy prohibited by the study protocol.
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT07164183
Start Date
September 11 2025
End Date
November 1 2026
Last Update
September 18 2025
Active Locations (8)
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1
Research Site
Kazan', Russia
2
Research Site
Moscow, Russia
3
Research Site
Rostov-on-Don, Russia
4
Research Site
Ryazan, Russia