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Recruiting Phase 2 NCT07260669

A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

Phase 2 – studying effectiveness and dosage
Conditions: Endometriosis

Sponsor: Gesynta Pharma AB

trial.available_in: БГ
Overview
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Who can participate
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.
Interventions
Vipoglanstat
DRUG
Placebo
DRUG
Locations 41
Bulgaria (3)
MHAT Puls AD
Blagoevgrad
Lyulin Hospital
Sofia
FemiClinic
Sofia
Czech Republic (5)
Gynekologie MEDA s.r.o
Brno
Fakultni nemocnice Brno
Brno
NEUMED Gynekologicka Ambulance s.r.o.
Olomouc
Gyncare MUDr. Michael Svec s.r.o.
Pilsen
STELLA-GYN, s.r.o.
Vodňany
Hungary (5)
MedEnd
Budapest
Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika
Budapest
Robert Karoly Private Hospital Tritonlife Medical Center
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
Kaposvár
Italy (1)
A.O. San Martino Genova Universita di Genova
Genova
Poland (13)
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
Bialystok
Centrum Ginekologii Artemida
Bialystok
In- Vivo Sp. z o. o.
Bydgoszcz
NZOZ Medem
Katowice
Centrum Medyczne Angelius Provita
Katowice
NZOZ Vita Longa Sp. z o.o.
Katowice
Medico Praktyka Lekarska
Krakow
Centrum Medyczne Chodzki
Lublin
ETG Siedlce
Siedlce
Aidport sp. Z o.o.
Skorzewo
Twoja Przychodnia SCM
Szczecin
Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
Warsaw
ETG JustMed
Warsaw
Romania (4)
Genesys Fertility Center
Bucharest
Delta Health Care
Bucharest
SC Centrul Medical Unirea SRL - Regina Maria
Iași
SC Centrul Medical Unirea SRL
Târgu Mureş
United Kingdom (10)
Accellacare Yorkshire
Bradford
Southmead Hospital - North Bristol NHS Trust
Bristol
Accellacare Northamptonshire
Corby
Accellacare Warwickshire
Coventry
Guy's and St Thomas' NHS Foundation Trust
London
Accellacare North London
Northwood
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Accellacare South London
Orpington
University of Oxford
Oxford
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
44 Years
Healthy volunteers
No
Start date
15.10.2025
Completion date
01.06.2027
Registry ID
NCT07260669
Source
clinicaltrials.gov
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