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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01779947 | Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo | PHASE3 | COMPLETED | 519 | — | — | Mar 1, 2012 | Dec 1, 2012 | Jun 26, 2014 | 25 | United States |
A responder was defined as a subject with at least a 25% reduction from baseline in the sum of % basal/parabasal and % intermediate cells on vaginal cytology AND vaginal pH \< 5.0 with a change from baseline vaginal pH of at least 0.5, where baseline values were collected at Visit 1
| Arm | Type | Description |
|---|---|---|
| Estradiol Vaginal Insert 10 mcg | EXPERIMENTAL | Estradiol Vaginal Insert 10 mcg - Test Product |
| Vagifem Tablets 10 mcg | ACTIVE_COMPARATOR | Vagifem® (Estradiol Vaginal Tablets) 10 mcg - Reference Listed Drug |
| Placebo | PLACEBO_COMPARATOR | Placebo for the test product Estradiol Vaginal Tablets 10 mcg |
| Name | Type | Description |
|---|---|---|
| Estradiol Vaginal Tablets 10 mcg | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Willing and able to provide and understand written informed consent for the study. * Healthy female subject aged 30 to 75 years, inclusive, who was postmenopausal, defined as having had 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follic...