Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 11:41 AM
Study NCT ID:
NCT06197568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study of Vaginal AZU-101 in Postmenopausal Women
Sponsor:
Azure Biotech Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Safety, Tolerability and Efficacy Study of Vaginal AZU-101 in Postmenopausal Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: