Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

NCT05378269 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-10-21

Study results available
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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

DRUG

Tamoxifen

Tamoxifen vaginal insert

OTHER

Placebo

Placebo vaginal insert

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2022-12-20
Completion
2023-03-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378269 on ClinicalTrials.gov