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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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