TUC3PII-01_TU2670 Phase IIa Clinical Study

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TiumBio Co., Ltd.

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.