Clinical Trial

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

Name: Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women — clinical trial record (NCT06315205)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: LEILA-1

Completed Phase 1

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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.

Protocol Amendment History 1 change

critical Trial completed 2026-07-25

Trial Details

NCT Number	NCT06315205
Lead Sponsor	Rovi Pharmaceuticals Laboratories
Conditions	Healthy
Enrollment	84 participants
Start Date	2023-07-26
Primary Completion	2026-03-11 (estimated)
Study Completion	2026-03-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-24