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

NCT06197568 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

  • Vulvo Vaginal Atrophy (VVA)

Interventions

DRUG

Lasofoxifene Tartrate

1.0 ug for 14 daily doses

Sponsors & Collaborators

  • Nucleus Network Ltd

    collaborator OTHER

  • Azure Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197568 on ClinicalTrials.gov