Vipoglanstat for endometriosis-related non‑menstrual pelvic pain in women
A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of 2 Doses of Vipoglanstat in Patients With Moderate to Severe Endometriosis-related Pain - the NOVA Trial
This study tests whether vipoglanstat can reduce non‑menstrual pelvic pain in premenopausal women with a confirmed diagnosis of endometriosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Gesynta Pharma AB Industry-sponsored |
| Locations | 41 sites (Blagoevgrad and 40 other locations) |
| Trial ID | NCT07260669 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives eligible premenopausal women either vipoglanstat or placebo and tracks their non‑menstrual pelvic pain during the treatment period. Eligible participants must have a documented diagnosis of endometriosis by surgery or imaging within the past 10 years or be diagnosed at screening. The primary focus is change in endometriosis‑related non‑menstrual pelvic pain using patient‑reported measures, with safety and tolerability also monitored. People whose pelvic pain is judged to be primarily from other causes are excluded.
Who should consider this trial
Good fit: Premenopausal women aged 18 to under 45 with documented endometriosis and a history of significant non‑menstrual pelvic pain are the intended participants.
Not a fit: Patients whose pelvic pain is primarily due to non‑endometriosis causes or who fall outside the specified age or diagnostic criteria are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, vipoglanstat could reduce non‑menstrual pelvic pain and improve daily functioning for women with endometriosis.
How similar studies have performed: While some medications have improved endometriosis pain in prior trials, vipoglanstat is a novel agent with limited published clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Blagoevgrad and 40 other locations
- MHAT Puls AD — Blagoevgrad, Bulgaria (Recruiting)
- Lyulin Hospital — Sofia, Bulgaria (Recruiting)
- FemiClinic — Sofia, Bulgaria (Recruiting)
- Gynekologie MEDA s.r.o — Brno, Czechia (Recruiting)
- Fakultni nemocnice Brno — Brno, Czechia (Recruiting)
- NEUMED Gynekologicka Ambulance s.r.o. — Olomouc, Czechia (Recruiting)
- Gyncare MUDr. Michael Svec s.r.o. — Pilsen, Czechia (Recruiting)
- STELLA-GYN, s.r.o. — Vodňany, Czechia (Recruiting)
- MedEnd — Budapest, Hungary (Recruiting)
- Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika — Budapest, Hungary (Recruiting)
- Robert Karoly Private Hospital Tritonlife Medical Center — Budapest, Hungary (Recruiting)
- Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary (Recruiting)
- Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital) — Kaposvár, Hungary (Recruiting)
- A.O. San Martino Genova Universita di Genova — Genova, Italy (Recruiting)
- Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O. — Bialystok, Poland (Recruiting)
- Centrum Ginekologii Artemida — Bialystok, Poland (Recruiting)
- In- Vivo Sp. z o. o. — Bydgoszcz, Poland (Recruiting)
- NZOZ Medem — Katowice, Poland (Recruiting)
- Centrum Medyczne Angelius Provita — Katowice, Poland (Recruiting)
- NZOZ Vita Longa Sp. z o.o. — Katowice, Poland (Recruiting)
- Medico Praktyka Lekarska — Krakow, Poland (Recruiting)
- Centrum Medyczne Chodzki — Lublin, Poland (Recruiting)
- ETG Siedlce — Siedlce, Poland (Recruiting)
- Aidport sp. Z o.o. — Skorzewo, Poland (Recruiting)
- Twoja Przychodnia SCM — Szczecin, Poland (Recruiting)
- Specjalistyczna Praktyka Lekarska Krzysztof Dynowski — Warsaw, Poland (Recruiting)
- ETG JustMed — Warsaw, Poland (Recruiting)
- Genesys Fertility Center — Bucharest, Romania (Recruiting)
- Delta Health Care — Bucharest, Romania (Recruiting)
- SC Centrul Medical Unirea SRL - Regina Maria — Iași, Romania (Recruiting)
- SC Centrul Medical Unirea SRL — Târgu Mureş, Romania (Recruiting)
- Accellacare Yorkshire — Bradford, United Kingdom (Recruiting)
- Southmead Hospital - North Bristol NHS Trust — Bristol, United Kingdom (Recruiting)
- Accellacare Northamptonshire — Corby, United Kingdom (Recruiting)
- Accellacare Warwickshire — Coventry, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- Accellacare North London — Northwood, United Kingdom (Recruiting)
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, United Kingdom (Recruiting)
- Accellacare South London — Orpington, United Kingdom (Recruiting)
- University of Oxford — Oxford, United Kingdom (Recruiting)
- Southampton General Hospital - University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: CMO VP Clinical Development
- Email: ctg@gesynta.se
- Phone: +46 762 788 389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.