drugset / Trial / NCT02874248
E4/DRSP Single and Multiple Dose PK and Early QT Study
RandomizedParallel-groupDouble-blindOther
Summary
This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).
Timeline
- Start
- 2016-05
- Primary completion
- 2016-11-21
- Completion
- 2016-11-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 15 mg | Oral |
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 30 mg | Oral |
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 60 mg | Oral |
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 75 mg | Oral |
| Comparator | drospirenone | Unknown | 3 mg | Oral |
| Comparator | drospirenone | Unknown | 6 mg | Oral |
| Comparator | drospirenone | Unknown | 12 mg | Oral |
| Comparator | drospirenone | Unknown | 15 mg | Oral |
Indications
No indication recorded.