drugset / Trial / NCT03401320
Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)
Non-randomizedSequentialOpen-labelOther
Summary
This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post menopausal women
Timeline
- Start
- 2017-11-06
- Primary completion
- 2024-05-17
- Completion
- 2024-05-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 50 mg | Intramuscular |
| Subject | Letrozole | Other / unclassified | 100 mg | Intramuscular |
| Subject | Letrozole | Other / unclassified | 200 mg | Intramuscular |
| Subject | Letrozole | Other / unclassified | 400 mg | Intramuscular |
Indications
No indication recorded.