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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2027-06-30

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose A Vipoglanstat

Group Type EXPERIMENTAL

Vipoglanstat

Intervention Type DRUG

Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

Dose B Vipoglanstat

Group Type EXPERIMENTAL

Vipoglanstat

Intervention Type DRUG

Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Placebo

Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gesynta Pharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MHAT Puls AD

Blagoevgrad, , Bulgaria

Site Status RECRUITING

Lyulin Hospital

Sofia, , Bulgaria

Site Status RECRUITING

Gynekologie MEDA s.r.o

Brno, , Czechia

Site Status RECRUITING

NEUMED Gynekologicka Ambulance s.r.o.

Olomouc, , Czechia

Site Status RECRUITING

STELLA-GYN, s.r.o.

Vodňany, , Czechia

Site Status RECRUITING

MedEnd

Budapest, , Hungary

Site Status RECRUITING

Robert Karoly Private Hospital Tritonlife Medical Center

Budapest, , Hungary

Site Status RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status RECRUITING

Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)

Kaposvár, , Hungary

Site Status RECRUITING

Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.

Bialystok, , Poland

Site Status RECRUITING

NZOZ Medem

Katowice, , Poland

Site Status RECRUITING

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status RECRUITING

NZOZ Vita Longa Sp. z o.o.

Katowice, , Poland

Site Status RECRUITING

Medico Praktyka Lekarska

Krakow, , Poland

Site Status RECRUITING

Centrum Medyczne Chodzki

Lublin, , Poland

Site Status RECRUITING

ETG Siedlce

Siedlce, , Poland

Site Status RECRUITING

Aidport sp. Z o.o.

Skorzewo, , Poland

Site Status RECRUITING

Twoja Przychodnia SCM

Szczecin, , Poland

Site Status RECRUITING

Specjalistyczna Praktyka Lekarska Krzysztof Dynowski

Warsaw, , Poland

Site Status RECRUITING

Accellacare Yorkshire

Bradford, , United Kingdom

Site Status RECRUITING

Accellacare Northamptonshire

Corby, , United Kingdom

Site Status RECRUITING

Accellacare Warwickshire

Coventry, , United Kingdom

Site Status RECRUITING

Accellacare North London

Northwood, , United Kingdom

Site Status RECRUITING

Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, , United Kingdom

Site Status RECRUITING

Accellacare South London

Orpington, , United Kingdom

Site Status RECRUITING

University of Oxford

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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Bulgaria Czechia Hungary Poland United Kingdom

Central Contacts

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CMO VP Clinical Development

Role: CONTACT

+46 762 788 389

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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