LEILA-1
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.
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
84
2 countries
3
Study Start
July 26, 2023
Actual (reported)Primary Completion
March 11, 2026
Actual (reported)Study Completion
March 11, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 26, 2023
Actual (reported)March 11, 2024
Actual (reported)March 18, 2024
Actual (reported)March 11, 2026
Actual (reported)March 11, 2026
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
λz
Terminal phase elimination rate constant
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
Cmax
Maximum observed plasma concentration after Letrozole LEBE administration
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
Clast
Last observed plasma concentration after Letrozole LEBE administration
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
tmax
Time to maximum observed concentration
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
E1
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
SE1
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
E2
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
λz
Following multiple oral administration of Femara (Treatment Period 1, Day 14)
Cav
Following multiple oral administration of Femara (Treatment Period 1, Day 14)
14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM injection of 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 150 mg
Investigational Site number CZ-01
Prague, Czechia
84 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
July 26, 2023
Actual (reported)tlag
Lag time before observation of quantifiable concentrations in plasma.
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
t1/2
Terminal elimination half life.
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
AUC∞
Area under the concentration time curve from time zero extrapolated to infinity.
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
AUClast
Area under the concentration time curve from time zero up to the last quantifiable concentration.
Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM injection of Letrozole LEBE 225mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 11, 2026
Actual (reported)Study Completion
March 11, 2026
Actual (reported)Last Updated
July 24, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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