Trials / Completed
CompletedNCT05367973
Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Daré Bioscience, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | IVR Dose 1 | Estradiol 80 ug/day + progesterone 4 mg/day |
| DEVICE | IVR Dose 2 | Estradiol 160 ug/day + progesterone 8 mg/day |
Timeline
- Start date
- 2022-04-11
- Primary completion
- 2023-01-09
- Completion
- 2023-03-23
- First posted
- 2022-05-10
- Last updated
- 2024-10-31
- Results posted
- 2024-10-31
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT05367973. Inclusion in this directory is not an endorsement.