NCT06315205View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Healthy
Interventions
DRUG

Letrozole LEBE 75 mg

14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM injection of Letrozole LEBE 75 mg

DRUG

Letrozole LEBE 150 mg

14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM injection of Letrozole LEBE 150 mg

DRUG

Letrozole LEBE 225 mg

14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM injection of Letrozole LEBE 225mg

Trial Locations (1)

Unknown

Investigational Site number CZ-01, Prague

All Listed Sponsors
lead

Rovi Pharmaceuticals Laboratories

INDUSTRY