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Recruiting NCT07260669

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

Phase II Interventional Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vipoglanstat, Placebo.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 18 years — 44 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria, Czechia, Hungary, Italy, Poland +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Vipoglanstat
    Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.
  • Drug Placebo
    Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.

Primary outcome measures

  • Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment [Time frame: Baseline to 4 months]
Secondary outcome measures (8)
  • Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment [Time frame: 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]
  • Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment [Time frame: 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]
  • Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment [Time frame: 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]
  • Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment [Time frame: Baseline to 4 months]
  • Number of Participants with Adverse Events [Time frame: Up to 10 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Poland · 13 centers
  • Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O. — Bialystok
  • Centrum Ginekologii Artemida — Bialystok
  • In- Vivo Sp. z o. o. — Bydgoszcz
  • NZOZ Medem — Katowice
  • Centrum Medyczne Angelius Provita — Katowice
  • NZOZ Vita Longa Sp. z o.o. — Katowice
  • Medico Praktyka Lekarska — Krakow
  • Centrum Medyczne Chodzki — Lublin
  • … and 5 more centers
United Kingdom · 10 centers
  • Accellacare Yorkshire — Bradford
  • Southmead Hospital - North Bristol NHS Trust — Bristol
  • Accellacare Northamptonshire — Corby
  • Accellacare Warwickshire — Coventry
  • Guy's and St Thomas' NHS Foundation Trust — London
  • Accellacare North London — Northwood
  • Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Fou — Norwich
  • Accellacare South London — Orpington
  • … and 2 more centers
Czechia · 5 centers
  • Gynekologie MEDA s.r.o — Brno
  • Fakultni nemocnice Brno — Brno
  • NEUMED Gynekologicka Ambulance s.r.o. — Olomouc
  • Gyncare MUDr. Michael Svec s.r.o. — Pilsen
  • STELLA-GYN, s.r.o. — Vodňany
Hungary · 5 centers
  • MedEnd — Budapest
  • Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika — Budapest
  • Robert Karoly Private Hospital Tritonlife Medical Center — Budapest
  • Debreceni Egyetem Klinikai Kozpont — Debrecen
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital) — Kaposvár
Romania · 4 centers
  • Genesys Fertility Center — Bucharest
  • Delta Health Care — Bucharest
  • SC Centrul Medical Unirea SRL - Regina Maria — Iași
  • SC Centrul Medical Unirea SRL — Târgu Mureş
Bulgaria · 3 centers
  • MHAT Puls AD — Blagoevgrad
  • Lyulin Hospital — Sofia
  • FemiClinic — Sofia
Italy · 1 center
  • A.O. San Martino Genova Universita di Genova — Genova

Identifiers

NCT: NCT07260669 · GS-248-203 · 2025-522452-16-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗