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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 4 Placebo capsules |
|
| TU2670 High Dose | Active Comparator | 320mg, QD |
|
| TU2670 Medium Dose | Active Comparator | 240 mg, QD |
|
| TU2670 Low Dose | Active Comparator | 120 mg, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Comparator: Placebo | Drug | 4 x placebo capsules, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| mean overall pelvic pain Numeric Rating Scale pain score |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density loss | Change from baseline to 12 weeks of treatment of the bone mineral density as assessed by dual-energy X-ray absorptiometry (DXA) | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | Hradec Kralove | 50005 | Czechia | ||
| Kestr-gyn s.r.o., Gynekologicka ambulance |
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| Active Comparator: TU2670 320mg |
| Drug |
320mg (80mg x 4), QD |
|
| Active Comparator: TU2670 240mg | Drug | 240mg (80mg x 3 + placebo x 1), QD |
|
| Active Comparator: TU2670 120mg | Drug | 120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD |
|
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) |
| 12 weeks |
| 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 | 12 weeks |
| rescue medication | Change from baseline to 12 weeks of treatment of the use of protocol-defined rescue medication (ie, ibuprofen) | 12 weeks |
| Time to increase of dose of rescue medication | Time to increase of dose of rescue medication from 0 week to 12 weeks | 12 weeks |
| Time to decrease of dose of rescue medication | Time to decrease of dose of rescue medication from 0 week to 12 weeks | 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) | 12 weeks |
| 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 | 12 weeks |
| 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) | 12 weeks |
| 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) | 12 weeks |
| 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) | 12 weeks |
| Náchod |
| Nachod |
| 54701 |
| Czechia |
| Fakultni Nemocnice Kralovske Vinohrady | Prague | Prague | 10034 | Czechia |
| OB/GYN | Prague | Praha 1 | 11000 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Dept. of Gynekologicko- porodnickaklinika 1.LF UK | Prague | Praha 2 | 128 08 | Czechia |
| University Hospital Brno | Brno | 62500 | Czechia |
| NEUMED gynekologicka ambulance | Olomouc | 77900 | Czechia |
| Nemocnice Na Bulovce | Prague | 18100 | Czechia |
| Università degli Studi di Cagliari - Policlinico Universitario Duilio Casula | Monserrato | Cagliari | 09042 | Italy |
| Azienda ospedaliero-universitaria Senese | Siena | Tuscany | 53100 | Italy |
| University of Florence | Florence | 50129 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano | Milan | 20122 | Italy |
| AZIENDA Ospedaliero Univeritaria Di Modena | Modena | 41124 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | 00168 | Italy |
| P.O. Sant'Anna | Torino | 10126 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |
| In Vivo sp. z o.o. | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85090 | Poland |
| Dolnośląskie Centrum Ginekologii | Wroclaw | Lower Silesian Voivodeship | 53333 | Poland |
| Komed Centra Kliniczne | Lublin | Lublin Voivodeship | 20362 | Poland |
| Hospital Pro-Familia | Rzeszów | Podkarpackie Voivodeship | 35-302 | Poland |
| Prywatna Klinika Położniczo-Ginekologiczna Sp. z o.o. | Bialystok | Podlaskie Voivodeship | 15224 | Poland |
| Centrum Medyczne Mikołowska | Katowice | Silesian Voivodeship | 40065 | Poland |
| Examen sp z o.o. | Skorzewo | Wielkopolska | 60185 | Poland |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian | Bialystok | 15267 | Poland |
| Provita Sp. z o.o. | Katowice | 40611 | Poland |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian, Fertility Clinic | Poznan | 60529 | Poland |
| Gameta Hospital | Rzeszów | Łódź Voivodeship | 95030 | Poland |
| Ural Research Institution of Maternity and Child Care of Russian Public Health Ministry | Yekaterinburg | Sverdlovsk Oblast | 620146 | Russia |
| State Institution of Healthcare Moscow City Clinical Hospital # 13 of Moscow Department | Moscow | 115280 | Russia |
| FSHI Clinical Hospital #85 of FMBA | Moscow | 115409 | Russia |
| Moscow State University of Medicine and Dentistry | Moscow | 127473 | Russia |
| SBIH Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Ivano-Frankivsk National Medical University on the basis of the municipal non-profit enterprise Ivano-Frankivsk Regional Perinatal Center of the Regional Council | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Communal non-commercial enterprise Vinnytsia City Clinical Hospital "Center of Mother and the Child | Vinnytsia | Vinnitsia | 21019 | Ukraine |
| Communal Nonprofit Enterprise Maternity Hospital#4 of Zaporizhzhya Municipal Council | Zaporizhzhya | Zaporizhzhia Oblast | 69065 | Ukraine |
| State Scientific Institution Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine | Kiev | 04053 | Ukraine |
| Kyiv city clinical hospital #9, Department of gynecology | Kyiv | 04112 | Ukraine |
| Lviv city clinical hospital #4 | Lviv | 79005 | Ukraine |
| Danylo Halytskyy Lviv national medical university | Lviv | 79010 | Ukraine |
| Private Small-Scale Enterprise Medical Centre Pulse | Vinnytsia | 21001 | Ukraine |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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