Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05378269
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2022-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
Sponsor:
Daré Bioscience, Inc.
Organization:
Study Overview
Official Title:
Phase 1/2 Study of Intravaginal Tamoxifen (DARE-VVA1): Randomized, Double-blind, Placebo-controlled Study of Safety, Pharmacokinetics and Pharmacodynamics in Postmenopausal Participants With Moderate to Sever Vulvar and Vaginal Atrophy
Status:
COMPLETED
Status Verified Date:
2024-07
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:
DARE-VVA1
Brief Summary:
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: