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Compares treatment options for Endometriosis
Official title Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
ClinicalTrials.gov ID: NCT07164183
What this study is testing
What is Indole-3-carbinol?
Indole-3-carbinol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for endometriosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- Participant has had spontaneous, (i.e., without hormonal therapy) regular, menstrual cycles with a cycle length between 24 to 38 days (inclusive) for...
- Participant has no current indications for surgical treatment of endometriosis.
You likely can't join if
- 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...
- Participant has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not...
- Endometrioid cysts ≥ 3 cm.
See the full eligibility criteria
- 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...
- 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...
- 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...
- Negative pregnancy test.
- Participant completed daily diary on minimum 75% of days during screening menstrual cycle.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kazan', Russia
- Moscow, Russia
- Rostov-on-Don, Russia
- Ryazan, Russia
- Saint Petersburg, Russia
- Smolensk, Russia
- Tver', Russia
- Yaroslavl, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kazan', Russia; Moscow, Russia; Rostov-on-Don, Russia; Ryazan, Russia; Saint Petersburg, Russia; Smolensk, Russia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.