Clinical Trial: NCT06315205
Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Rovi Pharmaceuticals Laboratories |
| Information Provided By: | Rovi Pharmaceuticals Laboratories |
| Last Update Posted: | 2026-07-24 |
Study Overview
Brief 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.
Conditions
Healthy
Intervention / Treatment
- Drug: Letrozole LEBE 75 mg
- Drug: Letrozole LEBE 150 mg
- Drug: Letrozole LEBE 225 mg
Other Study ID Numbers
- ROV-LEBE-2023-01
- 2023-503948-13
- 2023
Start Date (Actual)
2023-07-26
Primary Completion Date (Actual)
2026-03-11
Study Completion Date (Actual)
2026-03-11
Enrollment (Actual)
84
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Rovi Pharmaceuticals Laboratories |
| Information Provided By: | Rovi Pharmaceuticals Laboratories |
| Last Update Posted: | 2026-07-24 |
Study Overview
Brief 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.
Conditions
Healthy
Intervention / Treatment
- Drug: Letrozole LEBE 75 mg
- Drug: Letrozole LEBE 150 mg
- Drug: Letrozole LEBE 225 mg
Other Study ID Numbers
- ROV-LEBE-2023-01
- 2023-503948-13
- 2023
Start Date (Actual)
2023-07-26
Primary Completion Date (Actual)
2026-03-11
Study Completion Date (Actual)
2026-03-11
Enrollment (Actual)
84
Study Type
Interventional
Phase
Phase 1