Last updated on February 2018

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

Brief description of study

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

Detailed Study 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 50 weeks.

Clinical Study Identifier: NCT03401320

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Clinical Operations Rovi

Investigational Site Number 42001
Prague, Czechia
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