NCT05418426View on ClinicalTrials.gov

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 18, 2020

Primary Completion Date

April 27, 2021

Study Completion Date

January 27, 2022

Conditions
Vulvovaginal AtrophyVasomotor Symptoms
Interventions
DEVICE

IVR Dose 1

Estradiol 80 ug/progesterone 4 mg

DEVICE

IVR Dose 2

Estradiol 160ug/progesterone 8 mg

DRUG

Oral Reference

estradiol 1mg/progesterone 100 mg

Trial Locations (2)

Unknown

PARC Clinical Research, Melbourne

Keogh Institute for medical Research, Nedlands

Sponsors
All Listed Sponsors
lead

Daré Bioscience, Inc.

INDUSTRY