EndometriosisPhase 3BaikalNCT07164183
Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis
A Phase 3 study testing Indole-3-carbinol and Dienogest in people with Endometriosis, run by Alcea at 8 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Indole-3-carbinol and Dienogest
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 8 sitesRussia
- Study dates
- 11 Sep 2025to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Russia8 sites, 8 recruiting
- Not yet recruiting
Research Site
Kazan'
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Not yet recruiting
Research Site
Moscow
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Not yet recruiting
Research Site
Rostov-on-Don
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Recruiting
Research Site
Ryazan
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Not yet recruiting
Research Site
Saint Petersburg
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Recruiting
Research Site
Smolensk
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Not yet recruiting
Research Site
Tver'
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
- Recruiting
Research Site
Yaroslavl
Kirill Sokolov, MD, 7-495-502-9247, kirill.sokolov@alceapharma.ru
About this study
Official title: Prospective, Multicenter, Open-label, Randomized, Parallel Groups Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules (LLC Alcea, Russia) and Visanne 2 mg Tablets (BAYER AG, Germany) in Treatment of Endometriosis
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.
Read the 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, based on hypothesis of non-inferiority.
The study population consists of females from 18 to 45 years old inclusively at the moment of screening who have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within not more than 60 months and not less than 2 weeks of study entry, and reported at least moderate pelvic pain within minimum 2 months of study entry.
Study participants are observed during 1 menstrual cycle during screening period (Screening Cycle). Participants who meet inclusion criteria and don't meet exclusion criteria will be randomly assigned to one of two treatment arms (Group 1: Indinol Forto® 200 mg capsules two times per day or Group 2: Visanne 2 mg tablets once per day). After observation on treatment during 24 weeks (monthly Visits 1-7) the study subjects enter post-treatment period and are observed for one more month (Post-Treatment Period, Visit 8).
Visual Analog Scale (VAS) is used in the study as the main tool for assessment of daily pelvic pain. Cyclic and non-cyclic pain, as well as intensity of vaginal bleeding are assessed daily during the study.
The study primary efficacy endpoint is the change in average daily pelvic pain score (cyclic and non-cyclic, combined) during the 6th treatment period (interval between Visit 6 and Visit 7) in comparison to the Screening period.
- Conditions
- Endometriosis
- Being tested
- Indole-3-carbinol, Dienogest
- Keywords
- Endometriosis, Pelvic pain, Indinol Forto, indole-3-carbinol
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indole-3-carbinolDrug
Indinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks
DienogestDrug
Visanne (dienogest) 2 mg tablets orally once a day during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks Receives: Drug: Indole-3-carbinol |
| Arm 2 | Active comparator | Participants receive Visanne 2 mg tablets orally once a day during 24 weeks Receives: Drug: Dienogest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 7 (week 24)
Secondary outcomes (14)
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.
Measured: Visit 7 (week 24)
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.
Measured: Visit 7 (week 24)
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
Measured: Visit 7 (week 24)
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).
Measured: Visit 8 (week 28)
Proportion of participants with full recovery
Proportion of participants with complete absence of endometriosis symptoms, assessed with B\&B scale at Visit 7.
Measured: Visit 7 (week 24)
Proportion of participants with recurrence of endometriosis
Proportion of participants with recurrence of endometriosis symptoms, assessed with B\&B scale at Visit 8.
Measured: Visit 8 (week 28)
Quality of life change
Change in the quality of life assessment at Visits 2-8 in comparison to Visit 1 according to the EPH-30 questionnaire (total and in each of the modules).
Measured: Visit 8 (week 28)
Menstruation duration
Change in average duration of menstruation (in days) during Treatment Period and In Post-Treatment Period in comparison with Screening Cycle.
Measured: Visit 8 (week 28)
Menstruation intensity
Proportion of participants with more intensive, less intensive and normal menstruation during Treatment Period and In Post-Treatment Period in comparison with Screening Cycle.
Measured: Visit 8 (week 28)
Irregular vaginal bleeding
Proportion of participants with irregular vaginal bleeding during Treatment Periods and in Post-Treatment Period in comparison with Screening Cycle.
Measured: Visit 8 (week 28)
Proportion of participants with amenorrhea
Proportion of participants with amenorrhea during Treatment Periods and in Post-Treatment Period.
Measured: Visit 8 (week 28)
Number of menstruations
Number of menstruations (counted on day 1) registered during Treatment Periods.
Measured: Visit 8 (week 28)
Menstrual Cycle Duration
Duration of the last menstrual cycle (from day 1 of the previous menstruation to day 1 of the last menstruation) registered in the period from Visit 4 to Visit 7 (if applicable).
Measured: Visit 7 (week 24)
Endometriosis lesions size
Change in size of the biggest ovarian endometriosis lesion at Visit 7 in comparison to Screening ultrasound assessment.
Measured: Visit 7 (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start11 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164183
- Sponsor's protocol ID
- IND-III-2024
- Acronym
- Baikal
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open-label, Randomized, Parallel Groups Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules (LLC Alcea, Russia) and Visanne 2 mg Tablets (BAYER AG, Germany) in Treatment of Endometriosis
- ClinicalTrials.gov ID
- NCT07164183
- Acronym / sponsor ID
- Baikal / IND-III-2024
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Pelvic pain, Indinol Forto, indole-3-carbinol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- AlceaUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, based on hypothesis of non-inferiority.
The study population consists of females from 18 to 45 years old inclusively at the moment of screening who have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within not more than 60 months and not less than 2 weeks of study entry, and reported at least moderate pelvic pain within minimum 2 months of study entry.
Study participants are observed during 1 menstrual cycle during screening period (Screening Cycle). Participants who meet inclusion criteria and don't meet exclusion criteria will be randomly assigned to one of two treatment arms (Group 1: Indinol Forto® 200 mg capsules two times per day or Group 2: Visanne 2 mg tablets once per day). After observation on treatment during 24 weeks (monthly Visits 1-7) the study subjects enter post-treatment period and are observed for one more month (Post-Treatment Period, Visit 8).
Visual Analog Scale (VAS) is used in the study as the main tool for assessment of daily pelvic pain. Cyclic and non-cyclic pain, as well as intensity of vaginal bleeding are assessed daily during the study.
The study primary efficacy endpoint is the change in average daily pelvic pain score (cyclic and non-cyclic, combined) during the 6th treatment period (interval between Visit 6 and Visit 7) in comparison to the Screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Indole-3-carbinolParticipants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks |
| Arm 2 | Active comparator | Drug: DienogestParticipants receive Visanne 2 mg tablets orally once a day during 24 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indole-3-carbinolIndinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks | Drug | Arm 1 |
| DienogestVisanne (dienogest) 2 mg tablets orally once a day during 24 weeks | Drug | Arm 2 |
Primary outcome
Average daily pelvic pain score, combined
Time frame: Visit 7 (week 24)
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.
14 secondary outcomes
Average daily pelvic pain score, cyclic
Time frame: Visit 7 (week 24)
Average daily pelvic pain score, non-cyclic
Time frame: Visit 7 (week 24)
Proportion of participants with improvement
Time frame: Visit 7 (week 24)
Change in signs and symptoms of endometriosis assessed in B&B scale
Time frame: Visit 8 (week 28)
Proportion of participants with full recovery
Time frame: Visit 7 (week 24)
Proportion of participants with recurrence of endometriosis
Time frame: Visit 8 (week 28)
Quality of life change
Time frame: Visit 8 (week 28)
Menstruation duration
Time frame: Visit 8 (week 28)
Menstruation intensity
Time frame: Visit 8 (week 28)
Irregular vaginal bleeding
Time frame: Visit 8 (week 28)
Proportion of participants with amenorrhea
Time frame: Visit 8 (week 28)
Number of menstruations
Time frame: Visit 8 (week 28)
Menstrual Cycle Duration
Time frame: Visit 7 (week 24)
Endometriosis lesions size
Time frame: Visit 7 (week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indole-3-carbinol and Dienogest in people with Endometriosis, run by Alcea at 8 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily pelvic pain score, combined (time frame: Visit 7 (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.