A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis

Sponsor
Gesynta Pharma AB
Study ID
NCT07260669
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Vipoglanstat — DRUG
    Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
  • Placebo — DRUG
    Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

Study Details

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

Key Dates

First listed
Dec 3, 2025
Start date
Oct 15, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose A Vipoglanstat
  • Experimental: Dose B Vipoglanstat
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment [ Time Frame: Baseline to 4 months ]

Central Contacts

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