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drugset / Trial / NCT06197568

Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women

NCT06197568 ↗

Phase 2 Recruiting 90 enrolled Azure Biotech Inc. Nucleus Network Ltd · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Study Objectives: Primary: • To assess the safety, tolerability, and systemic pharmacokinetics (PK) of AZU-101 Secondary: • To evaluate efficacy of daily vaginal doses of AZU-101 in postmenopausal women on vaginal epithelium

Timeline

Start
2026-06-01
Primary completion
2026-12-31
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lasofoxifene Small molecule 0.1 ug Other
Subject Lasofoxifene Small molecule 0.5 ug Other
Subject Lasofoxifene Small molecule 1 ug Other

Indications

postmenopausal atrophic vaginitis