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Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women

NCT05367973 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-31

Study results available
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Summary

Randomized, Open-label 2-arm, parallel group study in approximately 20 healthy postmenopausal women to assess the safety of DARE-HRT1 Intravaginal Rings in two different dose strengths and the PK of progesterone and estradiol from the Intravaginal Rings.

Conditions

Interventions

DEVICE

IVR Dose 1

Estradiol 80 ug/day + progesterone 4 mg/day

DEVICE

IVR Dose 2

Estradiol 160 ug/day + progesterone 8 mg/day

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-01-09
Completion
2023-03-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05367973 on ClinicalTrials.gov