NCT06197568

Open-Label Study of Vaginal AZU-101 in Postmenopausal Women

An Open-Label, Safety, Tolerability and Efficacy Study of Vaginal AZU-101 in Postmenopausal Women

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Azure Biotech Inc. · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study Objectives: Primary ° To evaluate the safety and tolerability of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women Secondary * To assess systemic pharmacokinetics (PK) of AZU-101 * To assess the efficacy of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women

Detailed description

This is an open-label Phase 1b/2a study to evaluate the safety, pharmacokinetics (PK), and efficacy of vaginal AZU-101 in healthy postmenopausal female subjects over a period of 28 days. AZU-101 is a vaginal formulation of lasofoxifene tartrate, a selective estrogen receptor modulator (SERM). A total of 35 subjects, age 45 to 65 years, will be assigned to five cohorts (Cohorts 1-5) sequentially during enrollment (n=7/cohort). A once-weekly dose of AZU-101 will be administered at a dose of 0.1 μg (Cohort 1), 0.5 μg (Cohort 2), or 1 μg (Cohort 3) for 4 doses. A twice-weekly dose of AZU-101 will be administered at a dose of 0.1 μg (Cohort 4) or 0.5 μg (Cohort 5) for 8 doses. Safety and tolerability will be measured by vital signs, electrocardiogram (ECG) parameters, and the incidence of Treatment-Emergent Adverse Events (TEAEs) and concomitant treatments. The PK profile will be assessed using peak plasma concentration (Cmax), time to peak plasma concentration (tmax), and area-under-the-concentration-time-curve from time zero to infinity (AUC0-∞). Efficacy will be evaluated using vaginal pH, the vaginal Maturation Index (percentage of vaginal parabasal cells and superficial cells), and identification of the most bothersome symptom to the subject (dyspareunia, vaginal dryness, or vaginal irritation/itching).

Conditions

• Postmenopausal Symptoms

Interventions

Type	Name	Description
DRUG	Lasofoxifene Tartrate (AZU-101)	0.1 μg vaginal dose of AZU-101 weekly for 4 doses
DRUG	Lasofoxifene Tartrate (AZU-101)	0.5 μg vaginal dose of AZU-101 weekly for 4 doses
DRUG	Lasofoxifene Tartrate (AZU-101)	1 μg vaginal dose of AZU-101 weekly for 4 doses
DRUG	Lasofoxifene Tartrate (AZU-101)	0.1 μg vaginal dose of AZU-101 twice-weekly for 8 doses
DRUG	Lasofoxifene Tartrate (AZU-101)	0.5 μg vaginal dose of AZU-101 twice-weekly for 8 doses

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2024-01-09
• Last updated: 2025-10-15

Regulatory

• FDA-regulated drug study