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 (5) 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
United Kingdom
Accellacare Yorkshire
RECRUITING
Bradford
Accellacare Northamptonshire
RECRUITING
Corby
Accellacare Warwickshire
RECRUITING
Coventry
Accellacare North London
RECRUITING
Northwood
Accellacare South London
RECRUITING
Orpington
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