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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522452-16-00 | EU Trial (CTIS) Number |
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The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A Vipoglanstat | Experimental |
| |
| Dose B Vipoglanstat | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vipoglanstat | Drug | Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment | Baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment | Baseline to 4 months | |
| Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CMO VP Clinical Development | Contact | +46 762 788 389 | ctg@gesynta.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Puls AD | Recruiting | Blagoevgrad | 2700 | Bulgaria | ||
| Lyulin Hospital |
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| Placebo | Drug | Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period. |
|
| Baseline to 4 months |
| Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment | Baseline to 4 months |
| Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment | Baseline to 4 months |
| Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment | Baseline to 4 months |
| Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment | Baseline to 4 months |
| Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment | Baseline to 4 months |
| Number of Participants with Adverse Events | Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events. | Up to 10 months |
| Recruiting |
| Sofia |
| 1336 |
| Bulgaria |
| FemiClinic | Recruiting | Sofia | 1700 | Bulgaria |
| Gynekologie MEDA s.r.o | Recruiting | Brno | 60200 | Czechia |
| Fakultni nemocnice Brno | Recruiting | Brno | 62500 | Czechia |
| NEUMED Gynekologicka Ambulance s.r.o. | Recruiting | Olomouc | 77900 | Czechia |
| Gyncare MUDr. Michael Svec s.r.o. | Recruiting | Pilsen | 32600 | Czechia |
| STELLA-GYN, s.r.o. | Recruiting | Vodňany | 38901 | Czechia |
| MedEnd | Recruiting | Budapest | 1027 | Hungary |
| Semmelweis Egyetem II. Sz. Szuleszeti es Nogyogyaszati Klinika | Recruiting | Budapest | 1082 | Hungary |
| Robert Karoly Private Hospital Tritonlife Medical Center | Recruiting | Budapest | 1134 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Recruiting | Debrecen | 4032 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital) | Recruiting | Kaposvár | 7400 | Hungary |
| A.O. San Martino Genova Universita di Genova | Recruiting | Genova | 16132 | Italy |
| Prywatna Klinika Polozniczo - Ginekologiczna Sp. Z O.O. | Recruiting | Bialystok | 15-224 | Poland |
| Centrum Ginekologii Artemida | Recruiting | Bialystok | 15-464 | Poland |
| In- Vivo Sp. z o. o. | Recruiting | Bydgoszcz | 85-048 | Poland |
| NZOZ Medem | Recruiting | Katowice | 40-301 | Poland |
| Centrum Medyczne Angelius Provita | Recruiting | Katowice | 40-611 | Poland |
| NZOZ Vita Longa Sp. z o.o. | Recruiting | Katowice | 40-748 | Poland |
| Medico Praktyka Lekarska | Recruiting | Krakow | 31315 | Poland |
| Centrum Medyczne Chodzki | Recruiting | Lublin | 20-093 | Poland |
| ETG Siedlce | Recruiting | Siedlce | 08-110 | Poland |
| Aidport sp. Z o.o. | Recruiting | Skorzewo | 60-185 | Poland |
| Twoja Przychodnia SCM | Recruiting | Szczecin | 71-500 | Poland |
| Specjalistyczna Praktyka Lekarska Krzysztof Dynowski | Recruiting | Warsaw | 00-144 | Poland |
| ETG JustMed | Recruiting | Warsaw | 01-691 | Poland |
| Genesys Fertility Center | Recruiting | Bucharest | 012071 | Romania |
| Delta Health Care | Recruiting | Bucharest | 014142 | Romania |
| SC Centrul Medical Unirea SRL - Regina Maria | Recruiting | Iași | 700023 | Romania |
| SC Centrul Medical Unirea SRL | Recruiting | Târgu Mureş | 540139 | Romania |
| Accellacare Yorkshire | Recruiting | Bradford | BD18 3SA | United Kingdom |
| Southmead Hospital - North Bristol NHS Trust | Recruiting | Bristol | BS10 5NB | United Kingdom |
| Accellacare Northamptonshire | Recruiting | Corby | NN18 9EZ | United Kingdom |
| Accellacare Warwickshire | Recruiting | Coventry | CV3 4FJ | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
| Accellacare North London | Recruiting | Northwood | HA6 2RN | United Kingdom |
| Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust | Recruiting | Norwich | NR4 7UY | United Kingdom |
| Accellacare South London | Recruiting | Orpington | BR5 3QG | United Kingdom |
| University of Oxford | Recruiting | Oxford | OX3 9DU | United Kingdom |
| Southampton General Hospital - University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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