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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00630435 | Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation | PHASE1 | COMPLETED | 76 | — | — | Feb 1, 2008 | Jun 1, 2008 | Feb 4, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Premarin®/MPA formulation A | DRUG | - |
| Premarin®/MPA formulation B | DRUG | - |
| Premarin®/MPA formulation C | DRUG | - |
| Premarin®/MPA currently marketed product | DRUG | - |
Inclusion 1. Healthy postmenopausal women aged 35 to 70. 2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. 3. Nonsmoker or smoker of fewer than 10 cigarettes/day. Exclusion 1. History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 a...