Clinical trial
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
Aliases
NCT05138562, TUC3PII-01
Name
TUC3PII-01
Description
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.
Trial arms
Trial start
2021-08-19
Estimated PCD
2024-01-23
Trial end
2024-08-05
Status
Completed
Phase
Early phase I
Treatment
Placebo Comparator: Placebo
4 x placebo capsules, QD
Arms:
Placebo
Active Comparator: TU2670 320mg
320mg (80mg x 4), QD
Arms:
TU2670 High Dose
Active Comparator: TU2670 240mg
240mg (80mg x 3 + placebo x 1), QD
Arms:
TU2670 Medium Dose
Active Comparator: TU2670 120mg
120mg (80mg x 1 + 20mg x 2 + placebo x 1), QD
Arms:
TU2670 Low Dose
Size
86
Primary endpoint
overall pelvic pain
12 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 86, 'type': 'ACTUAL'}}
Updated at
2024-08-13
1 organization
Organization
TiumBio