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

April 16, 2026 updated by: Gesynta Pharma AB

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CMO VP Clinical Development
  • Phone Number: +46 762 788 389
  • Email: ctg@gesynta.se

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Recruiting
        • MHAT Puls AD
      • Sofia, Bulgaria, 1336
        • Recruiting
        • Lyulin Hospital
      • Sofia, Bulgaria, 1700
        • Recruiting
        • FemiClinic
  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultní nemocnice Brno
      • Brno, Czechia, 60200
        • Recruiting
        • Gynekologie MEDA s.r.o
      • Olomouc, Czechia, 77900
        • Recruiting
        • NEUMED Gynekologicka Ambulance s.r.o.
      • Pilsen, Czechia, 32600
        • Recruiting
        • Gyncare MUDr. Michael Svec s.r.o.
      • Vodňany, Czechia, 38901
        • Recruiting
        • STELLA-GYN, s.r.o.
  • Hungary
      • Budapest, Hungary, 1027
        • Recruiting
        • MedEnd
      • Budapest, Hungary, 1134
        • Recruiting
        • Robert Karoly Private Hospital Tritonlife Medical Center
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Kaposvár, Hungary, 7400
        • Recruiting
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • A.O. San Martino Genova Universita di Genova
  • Poland
      • Bialystok, Poland, 15-224
        • Recruiting
        • Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O.
      • Bialystok, Poland, 15-464
        • Recruiting
        • Centrum Ginekologii Artemida
      • Bydgoszcz, Poland, 85-048
        • Recruiting
        • In- Vivo Sp. z o. o.
      • Katowice, Poland, 40-611
        • Recruiting
        • Centrum Medyczne Angelius Provita
      • Katowice, Poland, 40-748
        • Recruiting
        • NZOZ Vita Longa Sp. z o.o.
      • Katowice, Poland, 40-301
        • Recruiting
        • NZOZ Medem
      • Krakow, Poland, 31315
        • Recruiting
        • Medico Praktyka Lekarska
      • Lublin, Poland, 20-093
        • Recruiting
        • Centrum Medyczne Chodzki
      • Siedlce, Poland, 08-110
        • Recruiting
        • ETG Siedlce
      • Skorzewo, Poland, 60-185
        • Recruiting
        • AIDPORT Sp. z o.o.
      • Szczecin, Poland, 71-500
        • Recruiting
        • Twoja Przychodnia SCM
      • Warsaw, Poland, 00-144
        • Recruiting
        • Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
      • Warsaw, Poland, 01-691
        • Recruiting
        • ETG JustMed
  • Romania
      • Bucharest, Romania, 014142
        • Recruiting
        • Delta Health Care
      • Bucharest, Romania, 012071
        • Recruiting
        • Genesys Fertility Center
      • Iași, Romania, 700023
        • Recruiting
        • SC Centrul Medical Unirea SRL - Regina Maria
      • Târgu Mureş, Romania, 540139
        • Recruiting
        • SC Centrul Medical Unirea SRL
  • United Kingdom
      • Bradford, United Kingdom, BD18 3SA
        • Recruiting
        • Accellacare Yorkshire
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital - North Bristol NHS Trust
      • Corby, United Kingdom, NN18 9EZ
        • Recruiting
        • Accellacare Northamptonshire
      • Coventry, United Kingdom, CV3 4FJ
        • Recruiting
        • Accellacare Warwickshire
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Accellacare North London
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Orpington, United Kingdom, BR5 3QG
        • Recruiting
        • Accellacare South London
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • University of Oxford
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.
Experimental: Dose A Vipoglanstat
Drug: Vipoglanstat
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
Experimental: Dose B Vipoglanstat
Drug: Vipoglanstat
Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment
Time Frame: Baseline to 4 months
Baseline to 4 months
Number of Participants with Adverse Events
Time Frame: Up to 10 months
Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events.
Up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gesynta Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-248-203
  • 2025-522452-16-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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