NCT05138562CompletedPhase 2
TUC3PII-01_TU2670 Phase IIa Clinical Study
A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects With Mod to Severe Endometriosis-Associated Pain
Source: ClinicalTrials.gov · Last updated 13 Aug 2024
Brief summary (registry, in English)
This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 25 Oct 2021
- Start date
- 19 Aug 2021
- Primary completion date
- 23 Jan 2024
- Lead sponsor
- TiumBio Co., Ltd.
- Diseases
- Endometriosis
- NCT number
- NCT05138562
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 19 Aug 2021 to the primary completion date, 23 Jan 2024
- 40 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks
- Subject has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis.
Who the study is looking for
- Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject.
- Premenopausal female subject, 18 to 45 years, inclusive
- Subject has moderate to severe endometriosis-related pain
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| University Hospital Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Kestr-gyn s.r.o., Gynekologicka ambulance Coordinator of this site? Confirm its status | Náchod | Czechia | Unknown status |
| NEUMED gynekologická ambulance Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Nemocnice Na Bulovce Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| OB/GYN Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University of Florence Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| AZIENDA Ospedaliero Univeritaria Di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula Coordinator of this site? Confirm its status | Monserrato | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| P.O. Sant'Anna Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Centrum Medyczne Mikołowska Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Komed Centra Kliniczne Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Hospital Pro-Familia Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| Gameta Hospital Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| Examen sp. z o.o. Coordinator of this site? Confirm its status | Skórzewo | Poland | Unknown status |
| Dolnośląskie Centrum Ginekologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| FSHI Clinical Hospital #85 of FMBA Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Moscow State University of Medicine and Dentistry Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| SBIH Leningrad Regional Clinical Hospital Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Unknown status |
| Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| Kyiv city clinical hospital #9, Department of gynecology Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Lviv City Clinical Hospital #4 Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Danylo Halytskyy Lviv national medical university Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Private Small-Scale Enterprise Medical Centre Pulse Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.