At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
Oral Reference +2 moredrug
Likely dose
Oral Reference 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80μg Estradiol/4mg Progesterone and 160μg Estradiol/8mg Progesterone Intravaginal Rings) in Healthy PostMenopausal Women
In Brief
A Phase 1 clinical trial evaluating IVR Dose 1, IVR Dose 2, and 1 other intervention for Vulvovaginal Atrophy and Vasomotor Symptoms. Completed, enrolled 34 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Atrophy, Vasomotor Symptoms
CountriesAustralia
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartAug 2020
Primary CompletionApr 2021
Study CompletionJan 2022
First PostedJun 2022
TodayJul 2026
First PostedJun 14, 2022
Enrollment StartAug 18, 2020
Primary CompletionApr 27, 2021
Study CompletionJan 27, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.0 years ago
Interventions
IVR Dose 1device
Estradiol 80 ug/progesterone 4 mg
IVR Dose 2device
Estradiol 160ug/progesterone 8 mg
Oral Referencedrug
estradiol 1mg/progesterone 100 mg