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ACTIVE NOT RECRUITING
NCT06315205
PHASE1

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

Sponsor: Rovi Pharmaceuticals Laboratories

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-07-26

Completion Date

2026-03

Last Updated

2026-03-04

Healthy Volunteers

Yes

Conditions

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

Locations (1)

Investigational Site number CZ-01

Prague, Czechia