search
Back to results

TUC3PII-01_TU2670 Phase IIa Clinical Study

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo Comparator: Placebo
Active Comparator: TU2670 320mg
Active Comparator: TU2670 240mg
Active Comparator: TU2670 120mg
Sponsored by
TiumBio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University Hospital Hradec KraloveRecruiting
  • Kestr-gyn s.r.o., Gynekologicka ambulanceRecruiting
  • OB/GYNRecruiting
  • Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UKRecruiting
  • Fakultni Nemocnice Kralovske VinohradyRecruiting
  • University Hospital BrnoRecruiting
  • NEUMED gynekologicka ambulanceRecruiting
  • Nemocnice Na BulovceRecruiting
  • Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula
  • Azienda ospedaliero-universitaria Senese
  • University of Florence
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano
  • AZIENDA Ospedaliero Univeritaria Di Modena
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • P.O. Sant'Anna
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Dolnośląskie Centrum GinekologiiRecruiting
  • In Vivo sp. z o.o.Recruiting
  • Gameta HospitalRecruiting
  • Komed Centra KliniczneRecruiting
  • Hospital Pro-FamiliaRecruiting
  • Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.Recruiting
  • Centrum Medyczne MikołowskaRecruiting
  • Examen sp z o.o.Recruiting
  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa BocianRecruiting
  • Provita Sp. z o.o.Recruiting
  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility ClinicRecruiting
  • Ural Research Institution of Maternity and Child Care of Russian Public Health MinistryRecruiting
  • State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow DepartmentRecruiting
  • FSHI Clinical Hospital #85 of FMBARecruiting
  • Moscow State University of Medicine and DentistryRecruiting
  • SBIH Leningrad Regional Clinical HospitalRecruiting
  • Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional CouncilRecruiting
  • Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the ChildRecruiting
  • Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal CouncilRecruiting
  • State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of UkraineRecruiting
  • Kyiv city clinical hospital #9, Department of gynecologyRecruiting
  • Lviv city clinical hospital #4Recruiting
  • Danylo Halytskyy Lviv national medical universityRecruiting
  • Private Small-Scale Enterprise Medical Centre PulseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

TU2670 High Dose

TU2670 Medium Dose

TU2670 Low Dose

Arm Description

4 Placebo capsules

320mg, QD

240 mg, QD

120 mg, QD

Outcomes

Primary Outcome Measures

overall pelvic pain
Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain score on menstrual bleeding days) as measured by the Numeric Rating Scale(minimum 0, maximum 10, higher score mean a worse outcome) over the past month.

Secondary Outcome Measures

mean Numeric Rating Scale pain score
Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) for non-menstrual pelvic pain (mean Numeric Rating Scale pain score on non menstrual bleeding days)
mean overall pelvic pain Numeric Rating Scale pain score
Change from baseline to 12 weeks of treatment of the mean overall pelvic pain Numeric Rating Scale pain score (mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) over all 28 days)
mean Numeric Rating Scale dyspareunia score
Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale((minimum 0, maximum 10, higher score mean a worse outcome) dyspareunia score
rescue medication
Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen)
Time to increase of dose of rescue medication
Time to increase of dose of rescue medication from 0 week to 12 weeks
Time to decrease of dose of rescue medication
Time to decrease of dose of rescue medication from 0 week to 12 weeks
Modified Biberoglu and Behrman sign and symptom scores
Change from baseline to 12 weeks of treatment of the Modified Biberoglu and Behrman (mB&B) sign and symptom scores(minimum 0, maximum 3, higher score mean a worse outcome)
Patient Global Impression of Change
Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome) at 12 weeks of treatment
Endometriosis Health Profile-5
Change from baseline to 12 weeks of treatment in the Endometriosis Health Profile-5 score(minimum 1(Never), maximum 5(Always), higher score mean a worse outcome)
36-Item Short Form Health Survey
Change from baseline to 12 weeks of treatment of the 36-Item Short Form Health Survey(Scoring meaning is different from the questions but usually lower score mean a worse outcome)
Work Productivity and Activity Impairment Questionnaire: General Health
Change from baseline to 12 weeks of treatment of the Work Productivity and Activity Impairment Questionnaire: General Health (Scoring meaning is different from the questions)

Full Information

First Posted
October 25, 2021
Last Updated
November 16, 2021
Sponsor
TiumBio Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05138562
Brief Title
TUC3PII-01_TU2670 Phase IIa Clinical Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TiumBio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Treatment Groups and Duration: Following a washout period of up to 12 weeks, subjects will enter a screening period of up to 12 weeks including an observation period consisting of a complete menstrual cycle. Subjects will be randomly assigned in a 1:1:1:1 ratio to receive either 12 weeks of TU2670 320 mg QD, TU2670 240 mg QD, TU2670 120 mg QD, or matching placebo. TU2670 or a matching placebo will be administered in the clinic on Day 1. Subjects in the PK subset population will also receive the following additional doses in the clinic: Day 2 (after collection of the 24-hour PK sample); the dose on the day scheduled for subsequent serial PK sample collection (Week 4 or Week 5); and the next scheduled dose (after collection of the 24-hour PK sample). All other doses can be taken by the subject at home. Following the end of treatment, subjects will be followed up for safety for 12 weeks. Statistical Methods: All formal statistical tests will be done at the 5% 2-sided significance level. Point estimates will have 2 sided 95% confidence intervals (CIs) where applicable. Where appropriate, variables will be summarized descriptively (frequency and percent will be summarized for categorical variables; n (number of available subjects), mean, standard deviation [SD], median, minimum, and maximum will be presented for continuous variables) by study visit and by treatment group. Statistical summaries will be presented for the changes from baseline to each time point in efficacy endpoints that it is applicable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 Placebo capsules
Arm Title
TU2670 High Dose
Arm Type
Active Comparator
Arm Description
320mg, QD
Arm Title
TU2670 Medium Dose
Arm Type
Active Comparator
Arm Description
240 mg, QD
Arm Title
TU2670 Low Dose
Arm Type
Active Comparator
Arm Description
120 mg, QD
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: Placebo
Intervention Description
4 x placebo capsules, QD
Intervention Type
Drug
Intervention Name(s)
Active Comparator: TU2670 320mg
Intervention Description
320mg (80mg x 4), QD
Intervention Type
Drug
Intervention Name(s)
Active Comparator: TU2670 240mg
Intervention Description
240mg (80mg x 3 + placebo x 1), QD
Intervention Type
Drug
Intervention Name(s)
Active Comparator: TU2670 120mg
Intervention Description
120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD
Primary Outcome Measure Information:
Title
overall pelvic pain
Description
Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain score on menstrual bleeding days) as measured by the Numeric Rating Scale(minimum 0, maximum 10, higher score mean a worse outcome) over the past month.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
mean Numeric Rating Scale pain score
Description
Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) for non-menstrual pelvic pain (mean Numeric Rating Scale pain score on non menstrual bleeding days)
Time Frame
12 weeks
Title
mean overall pelvic pain Numeric Rating Scale pain score
Description
Change from baseline to 12 weeks of treatment of the mean overall pelvic pain Numeric Rating Scale pain score (mean Numeric Rating Scale pain score(minimum 0, maximum 10, higher score mean a worse outcome) over all 28 days)
Time Frame
12 weeks
Title
mean Numeric Rating Scale dyspareunia score
Description
Change from baseline to 12 weeks of treatment of the mean Numeric Rating Scale((minimum 0, maximum 10, higher score mean a worse outcome) dyspareunia score
Time Frame
12 weeks
Title
rescue medication
Description
Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen)
Time Frame
12 weeks
Title
Time to increase of dose of rescue medication
Description
Time to increase of dose of rescue medication from 0 week to 12 weeks
Time Frame
12 weeks
Title
Time to decrease of dose of rescue medication
Description
Time to decrease of dose of rescue medication from 0 week to 12 weeks
Time Frame
12 weeks
Title
Modified Biberoglu and Behrman sign and symptom scores
Description
Change from baseline to 12 weeks of treatment of the Modified Biberoglu and Behrman (mB&B) sign and symptom scores(minimum 0, maximum 3, higher score mean a worse outcome)
Time Frame
12 weeks
Title
Patient Global Impression of Change
Description
Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome) at 12 weeks of treatment
Time Frame
12 weeks
Title
Endometriosis Health Profile-5
Description
Change from baseline to 12 weeks of treatment in the Endometriosis Health Profile-5 score(minimum 1(Never), maximum 5(Always), higher score mean a worse outcome)
Time Frame
12 weeks
Title
36-Item Short Form Health Survey
Description
Change from baseline to 12 weeks of treatment of the 36-Item Short Form Health Survey(Scoring meaning is different from the questions but usually lower score mean a worse outcome)
Time Frame
12 weeks
Title
Work Productivity and Activity Impairment Questionnaire: General Health
Description
Change from baseline to 12 weeks of treatment of the Work Productivity and Activity Impairment Questionnaire: General Health (Scoring meaning is different from the questions)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Bone mineral density loss
Description
Change from baseline to 12 weeks of treatment of the bone mineral density as assessed by dual-energy X-ray absorptiometry (DXA)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tium Bio
Phone
+82-31-600-1500
Email
NCE403_TU2670@tiumbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
SiYoo Lee
Phone
+82-31-600-1511
Email
siyoo@tiumbio.com
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
State/Province
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Mls
Phone
+420728489859
Email
jan.mls.gyn@gmail.com
Facility Name
Kestr-gyn s.r.o., Gynekologicka ambulance
City
Náchod
State/Province
Nachod
ZIP/Postal Code
54701
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Kestranek Site Address
Phone
+420491421883
Email
kestra@volny.cz
Facility Name
OB/GYN
City
Praha
State/Province
Praha 1
ZIP/Postal Code
11000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktor Kacer
Phone
+42222245565
Email
viktor.kacer@protonmail.com
Facility Name
Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK
City
Praha
State/Province
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Calda
Phone
+420224967273
Email
calda@gynstart.cz
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha 10
State/Province
Praha
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hruda
Phone
+420773622730
Email
martin.hruda@fnkv.cz
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hudecek
Phone
+420532232449
Email
hudecek.robert@fnbrno.cz
Facility Name
NEUMED gynekologicka ambulance
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Neubert
Phone
+420588517332
Email
neumed@seznam.cz
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
18100
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Zikan
Phone
+420266083229
Email
michal.zikan@bulovka.cz
Facility Name
Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Guerriero
Phone
+393487848668
Email
gineca.sguerriero@tiscali.it
Facility Name
Azienda ospedaliero-universitaria Senese
City
Siena
State/Province
Tuscany
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Centini
Phone
+39577585111
Email
centini.gabriele@gmail.com
Facility Name
University of Florence
City
Florence
ZIP/Postal Code
50129
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Elisabetta Coccia
Phone
+39557949926
Email
elisabetta.coccia@gmail.com
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Vercellini
Phone
+39255032318
Email
paolo.vercellini@unimi.it
Facility Name
AZIENDA Ospedaliero Univeritaria Di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Alboni
Phone
+39594224387
Email
alboni.carlo@aou.mo.it
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiorenzo De Cicco Nardone
Phone
+390630155131
Email
fiorenzo.decicconardone@policlinicogemelli.it
Facility Name
P.O. Sant'Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saverio Danese
Phone
+39011313444
Email
sdanese@cittadellasalute.to.it
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentino Bergamini
Phone
+390458122153
Email
valentino.bergamini@aovr.veneto.it
Facility Name
Dolnośląskie Centrum Ginekologii
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
53333
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariusz Markuszewski
Phone
+48717213200
Email
biuro@dcg.wroclaw.pl
Facility Name
In Vivo sp. z o.o.
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85090
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Szymanski
Phone
+48501109918
Email
kontakt@in-vivo.pl
Facility Name
Gameta Hospital
City
Rzeszów
State/Province
Lodzkie
ZIP/Postal Code
95030
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawel Radwan
Phone
+48426457777
Email
pradwan@gameta.pl
Facility Name
Komed Centra Kliniczne
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20362
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Gogacz
Phone
+48814402474
Email
marek.gogacz@komed-ck.pl
Facility Name
Hospital Pro-Familia
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Lozinski
Phone
+4817773700
Email
tomasz.lozinski@pro-familia.pl
Facility Name
Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o.
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15224
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Tomaszewski
Phone
+48602373927
Email
klinika.jtomaszewski@wp.pl
Facility Name
Centrum Medyczne Mikołowska
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40065
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Sipinski
Phone
+48601444059
Email
cmmkatowice@gmail.com
Facility Name
Examen sp z o.o.
City
Skorzewo
State/Province
Wielkopolska
ZIP/Postal Code
60185
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Szymanowski
Phone
+48618419324
Email
kp.szymanowski@wp.pl
Facility Name
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
City
Białystok
ZIP/Postal Code
15267
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Mrugacz
Phone
+48857447700
Email
gmrugacz@klinikabocian.pl
Facility Name
Provita Sp. z o.o.
City
Katowice
ZIP/Postal Code
40611
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariusz Kiecka
Phone
+48327837303
Email
m.kiecka@angelius.org
Facility Name
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic
City
Poznań
ZIP/Postal Code
60529
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olaf Lindert
Phone
+48327010460
Email
olaf.lindert@wp.pl
Facility Name
Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620146
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadezhda Bashmakova
Phone
+79122409205
Email
dr@niiomm.ru
Facility Name
State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Grigoryan
Phone
+70952743646
Email
9166852535@mail.ru
Facility Name
FSHI Clinical Hospital #85 of FMBA
City
Moscow
ZIP/Postal Code
115409
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Levakov
Phone
+74993248674
Email
levakoff@yandex.ru
Facility Name
Moscow State University of Medicine and Dentistry
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Kuzmin
Phone
+74993905778
Email
vnkuzmin@rambler.ru
Facility Name
SBIH Leningrad Regional Clinical Hospital
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Sergeeva
Phone
+78125927819
Email
irina-sergeeva@hotmail.com
Facility Name
Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council
City
Ivano-Frankivs'k
State/Province
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Makarchuk
Phone
+380342553165
Email
o_makarchuk@ukr.net
Facility Name
Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child
City
Vinnytsia
State/Province
Vinnitsia
ZIP/Postal Code
21019
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriy Hryhorenko
Phone
+380674302263
Email
ahryhorenko@gmail.com
Facility Name
Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council
City
Zaporizhzhya
State/Province
Zaporizhzhya Oblast
ZIP/Postal Code
69065
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galyna Reznichenko
Phone
+380617641734
Email
reznichenkog17@gmail.com
Facility Name
State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
City
Kiev
ZIP/Postal Code
04053
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetyana Tatarchuk
Phone
+380442721072
Email
prof.tatarchuk@gmail.com
Facility Name
Kyiv city clinical hospital #9, Department of gynecology
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya Zakharenko
Phone
+380444400366
Email
gynec9@gmail.com
Facility Name
Lviv city clinical hospital #4
City
Lviv
ZIP/Postal Code
79005
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadiia Ilkiv
Phone
+380986445126
Email
ngilkiv@gmail.com
Facility Name
Danylo Halytskyy Lviv national medical university
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serhiy Shurpyak
Phone
+380322766162
Email
shurpyak_serhiy@yahoo.com
Facility Name
Private Small-Scale Enterprise Medical Centre Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Taran
Phone
+380432612696
Email
taranoa@ukr.net

12. IPD Sharing Statement

Learn more about this trial

TUC3PII-01_TU2670 Phase IIa Clinical Study

We'll reach out to this number within 24 hrs