Status:
RECRUITING
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Lead Sponsor:
Gesynta Pharma AB
Conditions:
Endometriosis
Eligibility:
FEMALE
18-44 years
Phase:
PHASE2
Brief Summary
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT07260669
Start Date
October 15 2025
End Date
June 1 2027
Last Update
March 12 2026
Active Locations (30)
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1
MHAT Puls AD
Blagoevgrad, Bulgaria, 2700
2
Lyulin Hospital
Sofia, Bulgaria, 1336
3
Gynekologie MEDA s.r.o
Brno, Czechia, 60200
4
NEUMED Gynekologicka Ambulance s.r.o.
Olomouc, Czechia, 77900