Endometriosis
Conditions
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.
Interventions
4 x placebo capsules, QD
DRUGActive Comparator: TU2670 320mg
320mg (80mg x 4), QD
DRUGActive Comparator: TU2670 240mg
240mg (80mg x 3 + placebo x 1), QD
DRUGActive Comparator: TU2670 120mg
120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD
Sponsors
TiumBio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall pelvic pain | 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| mean Numeric Rating Scale pain score | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | Time to increase of dose of rescue medication from 0 week to 12 weeks |
| Modified Biberoglu and Behrman sign and symptom scores | 12 weeks | 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 | 12 weeks | Patient Global Impression of Change (minimum 1, maximum 7, higher score mean a worse outcome) at 12 weeks of treatment |
| Endometriosis Health Profile-5 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 to decrease of dose of rescue medication | 12 weeks | Time to decrease of dose of rescue medication from 0 week to 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density loss | 12 weeks | Change from baseline to 12 weeks of treatment of the bone mineral density as assessed by dual-energy X-ray absorptiometry (DXA) |
Countries
Czechia, Italy, Poland, Russia, Ukraine
Outcome results
None listed