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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]

Вторичные конечные точки (8)

• Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]
• Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]
• Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]
• Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment [Срок оценки: Baseline to 4 months]
• Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment [Срок оценки: Baseline to 4 months]
• Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]
• Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment [Срок оценки: Baseline to 4 months]
• Number of Participants with Adverse Events [Срок оценки: Up to 10 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Польша · 13 центров

• 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
• … и ещё 5 центров

Великобритания · 10 центров

• 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
• … и ещё 2 центра

Чехия · 5 центров

• 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

Венгрия · 5 центров

• 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

Румыния · 4 центра

• Genesys Fertility Center — Bucharest
• Delta Health Care — Bucharest
• SC Centrul Medical Unirea SRL - Regina Maria — Iași
• SC Centrul Medical Unirea SRL — Târgu Mureş

Болгария · 3 центра

• MHAT Puls AD — Blagoevgrad
• Lyulin Hospital — Sofia
• FemiClinic — Sofia

Италия · 1 центр

• A.O. San Martino Genova Universita di Genova — Genova

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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