Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05367973 | Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women | PHASE1 | COMPLETED | 21 | — | — | Apr 11, 2022 | Mar 23, 2023 | Oct 31, 2024 | 2 | Australia |
| NCT05418426 | A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women | PHASE1 | COMPLETED | 34 | — | — | Aug 18, 2020 | Jan 27, 2022 | Oct 15, 2024 | 2 | Australia |
To assess the safety and tolerability of DARE-HRT1 Intravaginal rings
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of estradiol in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of estrone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
To describe the Pharmacokinetic parameters of progesterone in dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
| Arm | Type | Description |
|---|---|---|
| IVR: Estradiol 80 ug/day + progesterone 4mg/day | EXPERIMENTAL | 12-week IVR 80/4 |
| IVR Estradiol 160 ug/day + progesterone 8 mg/day | EXPERIMENTAL | 12-week IVR 160/8 |
| IVR: estradiol 160 ug/day + progesterone 8mg /day | EXPERIMENTAL | 28-day IVR 160/8 |
| Oracle Estrace(R)/Prometrium(R) | ACTIVE_COMPARATOR | 29 days (estradiol 1mg/progesterone 100 mg oral capsule) |
| Name | Type | Description |
|---|---|---|
| IVR Dose 1 | DEVICE | Estradiol 80 ug/day + progesterone 4 mg/day |
| IVR Dose 2 | DEVICE | Estradiol 160 ug/day + progesterone 8 mg/day |
| Oral Reference | DRUG | estradiol 1mg/progesterone 100 mg |
Inclusion Criteria: 1. Postmenopausal women with a body mass index (BMI) ≥ 18 and ≤ 38 kg/m2. BMI = weight (kg)/(height \[m\])2 Postmenopausal is defined as 12-months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/m...