NCT05378269

Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Daré Bioscience, Inc. · Industry
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.

Conditions

• Vulvar Atrophy

Interventions

Type	Name	Description
DRUG	Tamoxifen	Tamoxifen vaginal insert
OTHER	Placebo	Placebo vaginal insert

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-12-20
• Completion: 2023-03-01
• First posted: 2022-05-18
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

2 sites across 1 country: Australia