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

Gesynta Pharma

Status and phase: Enrolling; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: Vipoglanstat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260669

GS-248-203

2025-522452-16-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 3 patient groups, including a placebo group

Dose A Vipoglanstat

Experimental group

Treatment:

Drug: Vipoglanstat

Dose B Vipoglanstat

Experimental group

Treatment:

Drug: Vipoglanstat

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo