A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
NCT ID: NCT07260669
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2025-10-15
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose A Vipoglanstat
Vipoglanstat
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
Dose B Vipoglanstat
Vipoglanstat
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
Placebo
Placebo
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
Interventions
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Vipoglanstat
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
Placebo
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
Eligibility Criteria
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Inclusion Criteria
* 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
* Has had more than 2 surgical procedures for endometriosis.
18 Years
44 Years
FEMALE
No
Sponsors
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Gesynta Pharma AB
INDUSTRY
Responsible Party
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Locations
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MHAT Puls AD
Blagoevgrad, , Bulgaria
Lyulin Hospital
Sofia, , Bulgaria
Gynekologie MEDA s.r.o
Brno, , Czechia
NEUMED Gynekologicka Ambulance s.r.o.
Olomouc, , Czechia
STELLA-GYN, s.r.o.
Vodňany, , Czechia
MedEnd
Budapest, , Hungary
Robert Karoly Private Hospital Tritonlife Medical Center
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
Kaposvár, , Hungary
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
Bialystok, , Poland
NZOZ Medem
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
NZOZ Vita Longa Sp. z o.o.
Katowice, , Poland
Medico Praktyka Lekarska
Krakow, , Poland
Centrum Medyczne Chodzki
Lublin, , Poland
ETG Siedlce
Siedlce, , Poland
Aidport sp. Z o.o.
Skorzewo, , Poland
Twoja Przychodnia SCM
Szczecin, , Poland
Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
Warsaw, , Poland
Accellacare Yorkshire
Bradford, , United Kingdom
Accellacare Northamptonshire
Corby, , United Kingdom
Accellacare Warwickshire
Coventry, , United Kingdom
Accellacare North London
Northwood, , United Kingdom
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Accellacare South London
Orpington, , United Kingdom
University of Oxford
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2025-522452-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
GS-248-203
Identifier Type: -
Identifier Source: org_study_id
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