A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
NCT07260669
· ctgov
recruiting
phase phase-2
- Enrollment
- 190
- Start
- 2025-10-15
- Completion
- 2027-06-01
- Last updated
- 2026-09-11
- Has results
- False
- Countries
- Bulgaria, Czechia, Hungary, Italy, Poland, Romania, United Kingdom
Conditions
Tagged with
Interventions
-
Vipoglanstat
DRUG
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
-
Placebo
DRUG
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
Eligibility criteria
Inclusion Criteria:
* Premenopausal females 18 to \< 45 years of age at the time of Visit 1.
* Endometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit based on:
* Surgical (via direct visualization or biopsy verified) or
* Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging \[MRI\].
* History of NMPP significantly affecting daily life confirmed at Visit 1.
* The participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on patient global assessment NMPP.
Exclusion Criteria:
* Chronic pelvic pain that is not judged to be primarily related to endometriosis (eg, chronic pelvic infection, interstitial cystitis, nerve entrapments or neuropathies, non-endometriosis-related pelvic adhesive disease, persistent symptomatic ovarian cyst \[eg, dermoid\], posttubal ligation, symptomatic hydrosalpinx, and vaginismus).
* Has had more than 2 surgical procedures for endometriosis.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine