Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IVR Dose 1, IVR Dose 2 · 2 trials · 2 indications
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...
IVR Dose 1 and IVR Dose 2 are investigational drug doses being studied for vulvovaginal atrophy, a condition involving thinning and inflammation of the vaginal walls. They are also being evaluated in the context of vasomotor symptoms, commonly known as hot flashes. These doses are part of the DARE-HRT1 program.
IVR Dose 1 and IVR Dose 2 are developed by Dare Bioscience, Inc., a biopharmaceutical company traded under the ticker symbol DARE. The company is conducting clinical trials to evaluate these doses for vulvovaginal atrophy and vasomotor symptoms.
IVR Dose 1 and IVR Dose 2 are in Phase 1 clinical development. Two Phase 1 trials have been completed, involving a total of 55 participants. The drug is investigational and has not been approved by regulatory authorities.
IVR Dose 1 and IVR Dose 2 have been studied in two completed Phase 1 trials. NCT05367973 evaluated DARE-HRT1 over 12 weeks in 21 healthy postmenopausal women. NCT05418426 assessed pharmacokinetics and safety in 34 healthy postmenopausal women. Both trials were conducted in Australia.
IVR Dose 1 and IVR Dose 2 are doses of the drug candidate DARE-HRT1. The clinical trials for these doses are titled as studies of DARE-HRT1, indicating that IVR Dose 1 and IVR Dose 2 refer to specific dose levels within the DARE-HRT1 development program.