drugset / Trial / NCT03075956
Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers
RandomizedParallel-groupOpen-labelOther
Summary
Estetrol (E4) is being developed in two indications supporting women health care: first E4 is combined with a progestin, \[drospirenone (DRSP)\] and is used as a new combined oral contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new hormone replacement therapy (HRT) for the treatment of menopause related symptoms. The current clinical trial is designed to collect more detailed information about the PK profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.
Timeline
- Start
- 2017-01-31
- Primary completion
- 2017-08-02
- Completion
- 2017-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 5 mg | Oral |
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 15 mg | Oral |
| Subject | ESTETROL ANHYDROUS | Other / unclassified | 45 mg | Oral |
Indications
No indication recorded.