A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Recruiting · NCT07260669 · Interventional (participants receive a specific treatment) · Lead sponsor: Gesynta Pharma AB
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboVipoglanstat
What this trial is about
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Who can take part
Age range
18 Years to 44 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
44 locations listed.
- Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O. - Bialystok, Poland
- Centrum Ginekologii Artemida - Bialystok, Poland
- MHAT Puls AD - Blagoevgrad, Bulgaria
- Accellacare Yorkshire - Bradford, United Kingdom
- Southmead Hospital - North Bristol NHS Trust - Bristol, United Kingdom
- Gynekologie MEDA s.r.o - Brno, Czechia
- Fakultni nemocnice Brno - Brno, Czechia
- Genesys Fertility Center - Bucharest, Romania
- Delta Health Care - Bucharest, Romania
- Spitalul Clinic Filantropia - Bucharest, Romania
- MedEnd - Budapest, Hungary
- Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika - Budapest, Hungary
- Robert Karoly Private Hospital Tritonlife Medical Center - Budapest, Hungary
- In- Vivo Sp. z o. o. - Bydgoszcz, Poland
- Accellacare Northamptonshire - Corby, United Kingdom
- Accellacare Warwickshire - Coventry, United Kingdom
- Debreceni Egyetem Klinikai Kozpont - Debrecen, Hungary
- A.O. San Martino Genova Universita di Genova - Genova, Italy
- SC Centrul Medical Unirea SRL - Regina Maria - Iași, Romania
- Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital) - Kaposvár, Hungary
- NZOZ Medem - Katowice, Poland
- Centrum Medyczne Angelius Provita - Katowice, Poland
- NZOZ Vita Longa Sp. z o.o. - Katowice, Poland
- Medico Praktyka Lekarska - Krakow, Poland
- Guy's and St Thomas' NHS Foundation Trust - London, United Kingdom
- Centrum Medyczne Chodzki - Lublin, Poland
- Accellacare North London - Northwood, United Kingdom
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust - Norwich, United Kingdom
- NEUMED Gynekologicka Ambulance s.r.o. - Olomouc, Czechia
- Accellacare South London - Orpington, United Kingdom
- University of Oxford - Oxford, United Kingdom
- Gyncare MUDr. Michael Svec s.r.o. - Pilsen, Czechia
- Fakultni nemocnice Kralovske Vinohrady - Prague, Czechia
- ETG Siedlce - Siedlce, Poland
- Aidport sp. Z o.o. - Skorzewo, Poland
- Lyulin Hospital - Sofia, Bulgaria
- FemiClinic - Sofia, Bulgaria
- Southampton General Hospital - University Hospital Southampton NHS Foundation Trust - Southampton, United Kingdom
- Twoja Przychodnia SCM - Szczecin, Poland
- Spitalul Clinic Judetean de Urgenta Targu-Mures - Târgu Mureş, Romania
- SC Centrul Medical Unirea SRL - Târgu Mureş, Romania
- STELLA-GYN, s.r.o. - Vodňany, Czechia
- Specjalistyczna Praktyka Lekarska Krzysztof Dynowski - Warsaw, Poland
- ETG JustMed - Warsaw, Poland