At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
IVR Dose 1 +1 moredevice
Likely dose
Not stated in 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 1/2,, Open-label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of DARE-HRT1 (80ug Estradiol/4 mg Progesterone and 160ug Estradiol/8 mg Progesterone Intravaginal Rings) Over 12 Weeks in Healthy Postmenopausal Women
In Brief
A Phase 2 clinical trial evaluating IVR Dose 1 and IVR Dose 2 for Vulvovaginal Atrophy and Vasomotor Symptoms. Completed, enrolled 21 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Atrophy, Vasomotor Symptoms
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartApr 2022
First PostedMay 2022
Primary CompletionJan 2023
Study CompletionMar 2023
TodayJul 2026
First PostedMay 10, 2022
Enrollment StartApr 11, 2022
Primary CompletionJan 9, 2023
Study CompletionMar 23, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.1 years ago
Interventions
IVR Dose 1device
Estradiol 80 ug/day + progesterone 4 mg/day
IVR Dose 2device
Estradiol 160 ug/day + progesterone 8 mg/day