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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Phase: Phase 1/2 to Phase 2v3 Show 12 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 35 to 90
    • Start date: May 1, 2026 to Jun 1, 2026
    • Primary endpoints: 1 to 4
    • Study sites: 0 to 1
    • Interventions: Lasofoxifene Tartrate (AZU-101) (Drug), Lasofoxifene Tartrate (AZU-101) (Drug), Lasofoxifene Tartrate (AZU-101) (Drug), Lasofoxifene… to Lasofoxifene Tartrate (Drug)
    • Eligibility criteria expanded, about 190 words
    • Secondary endpoints: 9 to 3
    • Study description shortened, about 11 words
    • Study arms: 5 to 2
    • Collaborators expanded, about 3 words
    • Study title expanded, about 5 words
  3. Primary completion date: Sep 2024 to Dec 31, 2026
    • Start date: May 2024 to May 1, 2026
    • Study completion date: Dec 2024 to Jun 30, 2027
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06197568
Lead Sponsor Azure Biotech Inc.
Collaborators: Nucleus Network Ltd
Conditions
(from sponsor)		 Vulvo Vaginal Atrophy (VVA)
Related terms Dyspareunia
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov