RecruitingPhase 2NCT06197568

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

A Double-blind, Randomized, Placebo-controlled Proof oF Concept Clinical Study to Evaluate the Safety, Pharmacokinetics, AND Pharmacodynamics of Vaginal AZU-101 (Lasofoxifene Tartrate) in Postmenopausal Women

Sponsor

Azure Biotech Inc.

Enrollment

90 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Vulvo Vaginal Atrophy (VVA)

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

Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lasofoxifene Tartrate for people with vulvo vaginal atrophy (vva). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLasofoxifene Tartrate

1.0 ug for 14 daily doses

Locations(1)

Nucleus Network

Saint Paul, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06197568