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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02092571 | A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women | PHASE1 | COMPLETED | 56 | — | — | Feb 1, 2014 | Aug 1, 2014 | Nov 9, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | 1 ring intravaginal for 7 days, produced from the new process |
| Treatment B | EXPERIMENTAL | 1 ring intravaginal for 7 days, produced from the legacy process |
| Name | Type | Description |
|---|---|---|
| Progesterone vaginal ring, | DRUG | Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA) |
Inclusion: 1. Naturally postmenopausal woman with an intact uterus, 40 to 70 years of age, inclusive. 2. The subject has serum estradiol and FSH levels that are consistent with the subject being postmenopausal. 3. The subject has no clinically significant abnormality findings observed during pelvic...