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Active, not recruiting Phase 2

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

NCT07260669 · tracked via the Priya Life Science UK tracker
Sponsor
Gesynta Pharma AB
Phase
Phase 2
Started
2025-10-15
Last updated
2026-10-20

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

VipoglanstatPlacebo

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.

Study summary

The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
44 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment — Baseline to 4 months

Trial sites (44)

FacilityCityRegionStatus
MHAT Puls AD Blagoevgrad Bulgaria
Lyulin Hospital Sofia Bulgaria
FemiClinic Sofia Bulgaria
Gynekologie MEDA s.r.o Brno Czechia
Fakultni nemocnice Brno Brno Czechia
NEUMED Gynekologicka Ambulance s.r.o. Olomouc Czechia
Gyncare MUDr. Michael Svec s.r.o. Pilsen Czechia
Fakultni nemocnice Kralovske Vinohrady Prague Czechia
STELLA-GYN, s.r.o. Vodňany Czechia
MedEnd Budapest Hungary
Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika 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
A.O. San Martino Genova Universita di Genova Genova Italy
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O. Bialystok Poland
Centrum Ginekologii Artemida Bialystok Poland
In- Vivo Sp. z o. o. Bydgoszcz 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
ETG JustMed Warsaw Poland
Genesys Fertility Center Bucharest Romania
Delta Health Care Bucharest Romania
Spitalul Clinic Filantropia Bucharest Romania
SC Centrul Medical Unirea SRL - Regina Maria Iași Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures Târgu Mureş Romania
SC Centrul Medical Unirea SRL Târgu Mureş Romania
Accellacare Yorkshire Bradford United Kingdom
Southmead Hospital - North Bristol NHS Trust Bristol United Kingdom
Accellacare Northamptonshire Corby United Kingdom
Accellacare Warwickshire Coventry United Kingdom
Guy's and St Thomas' NHS Foundation Trust London United Kingdom
Accellacare North London Northwood United Kingdom

+ 4 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07260669 on ClinicalTrials.gov ↗ ← All trials in the UK