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

Phase 2RecruitingNCT07260669

Gesynta Pharma AB190 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

190

Conditions

Endometriosis

Interventions

VipoglanstatDRUG

Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

PlaceboDRUG

Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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.

Locations (26)

MHAT Puls AD

Outcomes

Primary Outcomes

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