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

NCT07260669 | Recruiting Phase 2

• 2 other identifiers: GS-248-2032025-522452-16-00
• Study Type: interventional
• Target: 190
• Locations: 7 countries
• Sites: 41

Brief Summary

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

Conditions

Endometriosis

Keywords

Non-menstrual pelvic pain; Dysmenorrhea; Pelvic pain

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 4 months

Secondary Outcomes (8)

• Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment

  Baseline to 4 months

• Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment

  Baseline to 4 months

• Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment

  Baseline to 4 months

• Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment

  Baseline to 4 months

• Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment

  Baseline to 4 months

Study Arms (3)

Dose A Vipoglanstat

EXPERIMENTAL

Drug: Vipoglanstat

Dose B Vipoglanstat

EXPERIMENTAL

Drug: Vipoglanstat

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Vipoglanstat DRUG

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

Dose A Vipoglanstat; Dose B Vipoglanstat

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gesynta Pharma AB: lead

Study Sites (41)

MHAT Puls AD

Blagoevgrad, 2700, Bulgaria

RECRUITING

Lyulin Hospital

Sofia, 1336, Bulgaria

RECRUITING

FemiClinic

Sofia, 1700, Bulgaria

RECRUITING

Gynekologie MEDA s.r.o

Brno, 60200, Czechia

RECRUITING

Fakultni nemocnice Brno

Brno, 62500, Czechia

RECRUITING

NEUMED Gynekologicka Ambulance s.r.o.

Olomouc, 77900, Czechia

RECRUITING

Gyncare MUDr. Michael Svec s.r.o.

Pilsen, 32600, Czechia

RECRUITING

STELLA-GYN, s.r.o.

Vodňany, 38901, Czechia

RECRUITING

MedEnd

Budapest, 1027, Hungary

RECRUITING

Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika

Budapest, 1082, Hungary

RECRUITING

Robert Karoly Private Hospital Tritonlife Medical Center

Budapest, 1134, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

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

Kaposvár, 7400, Hungary

RECRUITING

A.O. San Martino Genova Universita di Genova

Genova, 16132, Italy

RECRUITING

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

Bialystok, 15-224, Poland

RECRUITING

Centrum Ginekologii Artemida

Bialystok, 15-464, Poland

RECRUITING

In- Vivo Sp. z o. o.

Bydgoszcz, 85-048, Poland

RECRUITING

NZOZ Medem

Katowice, 40-301, Poland

RECRUITING

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

RECRUITING

NZOZ Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

RECRUITING

Medico Praktyka Lekarska

Krakow, 31315, Poland

RECRUITING

Centrum Medyczne Chodzki

Lublin, 20-093, Poland

RECRUITING

ETG Siedlce

Siedlce, 08-110, Poland

RECRUITING

Aidport sp. Z o.o.

Skorzewo, 60-185, Poland

RECRUITING

Twoja Przychodnia SCM

Szczecin, 71-500, Poland

RECRUITING

Specjalistyczna Praktyka Lekarska Krzysztof Dynowski

Warsaw, 00-144, Poland

RECRUITING

ETG JustMed

Warsaw, 01-691, Poland

RECRUITING

Genesys Fertility Center

Bucharest, 012071, Romania

RECRUITING

Delta Health Care

Bucharest, 014142, Romania

RECRUITING

SC Centrul Medical Unirea SRL - Regina Maria

Iași, 700023, Romania

RECRUITING

SC Centrul Medical Unirea SRL

Târgu Mureş, 540139, Romania

RECRUITING

Accellacare Yorkshire

Bradford, BD18 3SA, United Kingdom

RECRUITING

Southmead Hospital - North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

RECRUITING

Accellacare Northamptonshire

Corby, NN18 9EZ, United Kingdom

RECRUITING

Accellacare Warwickshire

Coventry, CV3 4FJ, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Accellacare North London

Northwood, HA6 2RN, United Kingdom

RECRUITING

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

Norwich, NR4 7UY, United Kingdom

RECRUITING

Accellacare South London

Orpington, BR5 3QG, United Kingdom

RECRUITING

University of Oxford

Oxford, OX3 9DU, United Kingdom

RECRUITING

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometriosis; Dysmenorrhea; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

CMO VP Clinical Development

CONTACT

+46 762 788 389; ctg@gesynta.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 3, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); PL (13); GB (10); CZ (5); HU (5); RO (4); IT (1)