Vipoglanstat for endometriosis-related non‑menstrual pelvic pain in women

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

Phase 2 Interventional Gesynta Pharma AB · NCT07260669

This study tests whether vipoglanstat can reduce non‑menstrual pelvic pain in premenopausal women with a confirmed diagnosis of endometriosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years to 44 Years
SexFemale
SponsorGesynta Pharma AB Industry-sponsored
Locations41 sites (Blagoevgrad and 40 other locations)
Trial IDNCT07260669 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives eligible premenopausal women either vipoglanstat or placebo and tracks their non‑menstrual pelvic pain during the treatment period. Eligible participants must have a documented diagnosis of endometriosis by surgery or imaging within the past 10 years or be diagnosed at screening. The primary focus is change in endometriosis‑related non‑menstrual pelvic pain using patient‑reported measures, with safety and tolerability also monitored. People whose pelvic pain is judged to be primarily from other causes are excluded.

Who should consider this trial

Good fit: Premenopausal women aged 18 to under 45 with documented endometriosis and a history of significant non‑menstrual pelvic pain are the intended participants.

Not a fit: Patients whose pelvic pain is primarily due to non‑endometriosis causes or who fall outside the specified age or diagnostic criteria are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, vipoglanstat could reduce non‑menstrual pelvic pain and improve daily functioning for women with endometriosis.

How similar studies have performed: While some medications have improved endometriosis pain in prior trials, vipoglanstat is a novel agent with limited published clinical data to date.

Eligibility criteria

Show full inclusion / exclusion criteria
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.

Where this trial is running

Blagoevgrad and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions EndometriosisNon-menstrual pelvic painDysmenorrheaPelvic pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.