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Clinical Trials/NCT07260669
NCT07260669
Recruiting
Phase 2

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 AB46 sites in 7 countries190 target enrollmentStarted: October 15, 2025Last updated:
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InterventionsVipoglanstatPlacebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
190
Locations
46
Primary Endpoint
Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Premenopausal females 18 to \< 45 years of age at the time of Visit
  • •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
  • •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.

Arms & Interventions

Dose A Vipoglanstat

Experimental

Intervention: Vipoglanstat (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Dose B Vipoglanstat

Experimental

Intervention: Vipoglanstat (Drug)

Outcomes

Primary Outcomes

Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment

Time Frame: Baseline to 4 months

Secondary Outcomes

  • Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment(Baseline to 4 months)
  • Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment(Baseline to 4 months)
  • Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment(Baseline to 4 months)
  • Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment(Baseline to 4 months)
  • Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment(Baseline to 4 months)
  • Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment(Baseline to 4 months)
  • Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment(Baseline to 4 months)
  • Number of Participants with Adverse Events(Up to 10 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (46)

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