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

NCT05418426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-10-15

Study results available
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Summary

An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.

Conditions

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

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • David Friend, PhD · Dare Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-04-27
Completion
2022-01-27

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 NCT05418426 on ClinicalTrials.gov