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

Last updated: October 19, 2026
Sponsor: Gesynta Pharma AB
Overall Status: Active - Not Recruiting

Phase

2

Condition

Severe Premenstrual Symptom

Dysmenorrhea (Painful Periods)

Endometriosis

Treatment

Placebo

Vipoglanstat

Clinical Study ID

NCT07260669
GS-248-203
2025-522452-16-00
2025
  • Ages 18-44
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 toVisit 1 or during Visit based on:

  • Surgical (via direct visualization or biopsy verified) or

  • Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography ormagnetic 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-menstrualdays in the month prior to Visit 2, based on patient global assessment NMPP.

Exclusion

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 ovariancyst [eg, dermoid], posttubal ligation, symptomatic hydrosalpinx, and vaginismus).

  • Has had more than 2 surgical procedures for endometriosis.

Study Design

Total Participants: 213
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 15, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • MHAT Puls AD

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • FemiClinic

    Sofia, 1700
    Bulgaria

    Site Not Available

  • Lyulin Hospital

    Sofia, 1336
    Bulgaria

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 62500
    Czechia

    Site Not Available

  • Gynekologie MEDA s.r.o

    Brno, 60200
    Czechia

    Site Not Available

  • NEUMED Gynekologicka Ambulance s.r.o.

    Olomouc, 77900
    Czechia

    Site Not Available

  • Gyncare MUDr. Michael Svec s.r.o.

    Pilsen, 32600
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34
    Czechia

    Site Not Available

  • STELLA-GYN, s.r.o.

    Vodňany, 38901
    Czechia

    Site Not Available

  • MedEnd

    Budapest, 1027
    Hungary

    Site Not Available

  • Robert Karoly Private Hospital Tritonlife Medical Center

    Budapest, 1134
    Hungary

    Site Not Available

  • Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika

    Budapest, 1082
    Hungary

    Site Not Available

  • Robert Karoly Private Hospital Tritonlife Medical Center

    Budapest 3054643, 1134
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

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

    Kaposvár, 7400
    Hungary

    Site Not Available

  • A.O. San Martino Genova Universita di Genova

    Genova, 16132
    Italy

    Site Not Available

  • Centrum Ginekologii Artemida

    Bialystok, 15-464
    Poland

    Site Not Available

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

    Bialystok, 15-224
    Poland

    Site Not Available

  • In- Vivo Sp. z o. o.

    Bydgoszcz, 85-048
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • NZOZ Medem

    Katowice, 40-301
    Poland

    Site Not Available

  • NZOZ Vita Longa Sp. z o.o.

    Katowice, 40-748
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice 3096472, 40-611
    Poland

    Active - Recruiting

  • NZOZ Medem

    Katowice 3096472, 40-301
    Poland

    Active - Recruiting

  • Provita Sp.zo.o. Centrum Medyczne Angelius

    Katowice 3096472, 40-611
    Poland

    Active - Recruiting

  • Medico Praktyka Lekarska

    Krakow, 31315
    Poland

    Site Not Available

  • Centrum Medyczne Chodzki

    Lublin, 20-093
    Poland

    Site Not Available

  • Centrum Medyczne Chodzki HLK

    Lublin 765876, 20-093
    Poland

    Active - Recruiting

  • ETG Siedlce

    Siedlce, 08-110
    Poland

    Site Not Available

  • Aidport sp. Z o.o.

    Skorzewo, 60-185
    Poland

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, 71-500
    Poland

    Site Not Available

  • ETG JustMed

    Warsaw, 01-691
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska Krzysztof Dynowski

    Warsaw, 00-144
    Poland

    Site Not Available

  • Delta Health Care

    Bucharest, 014142
    Romania

    Site Not Available

  • Genesys Fertility Center

    Bucharest, 012071
    Romania

    Site Not Available

  • Spitalul Clinic Filantropia

    Bucharest,
    Romania

    Site Not Available

  • SC Centrul Medical Unirea SRL - Regina Maria

    Iași, 700023
    Romania

    Site Not Available

  • SC Centrul Medical Unirea SRL

    Târgu Mureş, 540139
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu-Mures

    Târgu Mureş, 540136
    Romania

    Site Not Available

  • Accellacare Yorkshire

    Bradford, BD18 3SA
    United Kingdom

    Site Not Available

  • Southmead Hospital - North Bristol NHS Trust

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Accellacare Northamptonshire

    Corby, NN18 9EZ
    United Kingdom

    Site Not Available

  • Accellacare Warwickshire

    Coventry, CV3 4FJ
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Accellacare North London

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

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

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Accellacare South London

    Orpington, BR5 3QG
    United Kingdom

    Site Not Available

  • University of Oxford

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

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