drugset
drugset / Trial / NCT06315205

Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women

NCT06315205 ↗

Phase 1 Active not recruiting 90 enrolled Rovi Pharmaceuticals Laboratories
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy post-menopausal women.

Timeline

Start
2023-07-26
Primary completion
2026-03
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 75 mg Intramuscular
Subject Letrozole Other / unclassified 150 mg Intramuscular
Subject Letrozole Other / unclassified 225 mg Intramuscular

Indications

No indication recorded.