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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06668896 | Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert | PHASE1 | NOT YET_RECRUITING | 60 | — | — | Sep 1, 2026 | Apr 1, 2028 | May 8, 2026 | - | — |
Describe the concentration of progesterone (P4) in blood prior to, during and after 24 hours of DARE-PTB1 IVR (8mg and 12mg) over 14 days of use.
| Arm | Type | Description |
|---|---|---|
| DARE-PTB1 8mg IVR | EXPERIMENTAL | Intravaginal ring containing 8mg progesterone administered once for 14 days. |
| DARE-PTB1 12mg IVR | EXPERIMENTAL | Intravaginal ring containing 12mg progesterone administered once for 14 days. |
| DARE-PTB1 12mg IVR every 3 days | EXPERIMENTAL | Intravaginal ring containing 12mg progesterone administered every 3 days for 15 days. |
| Endometrin 100mg | ACTIVE_COMPARATOR | 100mg progesterone vaginal insert, three times daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| Progesterone | DRUG | Each arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period. |
Inclusion Criteria: * Individuals assigned female at birth who are post-menopausal, women 40 to 65 years of age, inclusive. Postmenopausal is defined as 6-months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL (if not taking systemic hormone therapy) or 6 weeks postsurgical bilateral o...