A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
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
Gesynta Pharma AB
190 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
Summary
The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
Eligibility
Inclusion Criteria6
- 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 Criteria2
- 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.
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Interventions
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
Locations(30)
View Full Details on ClinicalTrials.gov
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NCT07260669