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Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)

Healthy Clinical Trial

Official title:
A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole ISM® at Different Strengths in Voluntary Healthy Post Menopausal Women (LISA-1)

Clinical Trial 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

Clinical Trial Description

The objective of this study is to assess the pharmacokinetic profile of a single ascending doses of Letrozole ISM® (Rovi), and secondly, to evaluate safety and tolerability of single ascending doses of Letrozole ISM, measure estrogen levels, and characterize oral letrozole pharmacokinetic profile to be used in subsequent comparison to Letrozole ISM. The study will be carried out in healthy post-menopausal women who satisfy inclusion and exclusion criteria. The study design includes a screening period and 2 treatment periods. Treatment Period 1 will comprise of 14 oral dose administrations of 2.5 mg Femara®. Treatment Period 2 will comprise of a single IM dose of 50, 100, 200 and 400 mg Letrozole ISM®. The total planned study duration is 71 weeks, approximately. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03401320
Study type Interventional
Source Rovi Pharmaceuticals Laboratories
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 6, 2017
Completion date May 2024
View Details
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