Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis

NCT07164183 | Recruiting Phase 3

• 1 other identifier: IND-III-2024
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 8

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, based on hypothesis of non-inferiority.

Conditions

Endometriosis

Keywords

Endometriosis; Pelvic pain; Indinol Forto; indole-3-carbinol

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 7 (week 24)

Secondary Outcomes (14)

• Average daily pelvic pain score, cyclic

  Visit 7 (week 24)

• Average daily pelvic pain score, non-cyclic

  Visit 7 (week 24)

• Proportion of participants with improvement

  Visit 7 (week 24)

• Change in signs and symptoms of endometriosis assessed in B&B scale

  Visit 8 (week 28)

• Proportion of participants with full recovery

  Visit 7 (week 24)

Other Outcomes (3)

• Estrogens level

  Visit 7 (week 24)

• Estrogens index

  Visit 7 (week 24)

• Ferritin level

  Visit 7 (week 24)

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks

Drug: Indole-3-carbinol

Arm 2

ACTIVE COMPARATOR

Participants receive Visanne 2 mg tablets orally once a day during 24 weeks

Drug: Dienogest

Interventions

Indole-3-carbinol DRUG

Indinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks

Arm 1

Dienogest DRUG

Visanne (dienogest) 2 mg tablets orally once a day during 24 weeks

Arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female participants in reproductive/premenopausal period from 18 to 45 years old inclusively (at the moment of signing informed consent).
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Alcea: lead

Study Sites (8)

Research Site

Kazan', Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

NOT YET RECRUITING

Research Site

Rostov-on-Don, Russia

NOT YET RECRUITING

Research Site

Ryazan, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

NOT YET RECRUITING

Research Site

Smolensk, Russia

RECRUITING

Research Site

Tver', Russia

NOT YET RECRUITING

Research Site

Yaroslavl, Russia

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

indole-3-carbinol; dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

RU (8)