Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-05
Brief Title:
Open-Label Study of Vaginal AZU-101 in Postmenopausal Women
Sponsor:
Azure Biotech Inc
Organization:
Azure Biotech Inc
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:
2023-12
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 1b2a 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 n7cohort A once-weekly dose of AZU-101 will be administered at a dose of 01 μg Cohort 1 05 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 01 μg Cohort 4 or 05 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 irritationitching
A total of 35 subjects age 45 to 65 years will be assigned to five cohorts Cohorts 1-5 sequentially during enrollment n7cohort A once-weekly dose of AZU-101 will be administered at a dose of 01 μg Cohort 1 05 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 01 μg Cohort 4 or 05 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 irritationitching
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None