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
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Bulgaria
MHAT Puls AD
RECRUITING
Blagoevgrad
FemiClinic
RECRUITING
Sofia
Lyulin Hospital
RECRUITING
Sofia
Hungary
MedEnd
RECRUITING
Budapest
Robert Karoly Private Hospital Tritonlife Medical Center
RECRUITING
Budapest
Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
RECRUITING
Kaposvár
Italy
A.O. San Martino Genova Universita di Genova
RECRUITING
Genova
Poland
Centrum Ginekologii Artemida
RECRUITING
Bialystok
Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
RECRUITING
Bialystok
In- Vivo Sp. z o. o.
RECRUITING
Bydgoszcz
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
NZOZ Medem
RECRUITING
Katowice
NZOZ Vita Longa Sp. z o.o.
RECRUITING
Katowice
Medico Praktyka Lekarska
RECRUITING
Krakow
Centrum Medyczne Chodzki
RECRUITING
Lublin
ETG Siedlce
RECRUITING
Siedlce
Aidport sp. Z o.o.
RECRUITING
Skorzewo
Twoja Przychodnia SCM
RECRUITING
Szczecin
ETG JustMed
RECRUITING
Warsaw
Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
RECRUITING
Warsaw
Romania
Delta Health Care
RECRUITING
Bucharest
Genesys Fertility Center
RECRUITING
Bucharest
SC Centrul Medical Unirea SRL - Regina Maria
RECRUITING
Iași
SC Centrul Medical Unirea SRL
RECRUITING
Târgu Mureş
United Kingdom
Accellacare Yorkshire
RECRUITING
Bradford
Southmead Hospital - North Bristol NHS Trust
RECRUITING
Bristol
Accellacare Northamptonshire
RECRUITING
Corby
Accellacare Warwickshire
RECRUITING
Coventry
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Accellacare North London
RECRUITING
Northwood
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Accellacare South London
RECRUITING
Orpington
University of Oxford
RECRUITING
Oxford
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
CMO VP Clinical Development
ctg@gesynta.se
+46 762 788 389
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2027-06
Participants
Target number of participants: 190
Treatments
Experimental: Dose A Vipoglanstat
Experimental: Dose B Vipoglanstat
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Gesynta Pharma AB