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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01359163 | A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2011 | Jul 1, 2011 | Apr 4, 2012 | 1 | Singapore |
| Arm | Type | Description |
|---|---|---|
| Femulen commercial tablets | ACTIVE_COMPARATOR | - |
| Femulen reformulated tablets | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| etynodiol diacetate | DRUG | tablet, 0.5 mg, single dose |
Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical e...