Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR)
2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar
2015-Mar 2024.
This study is a prospective observational study in which female patients undergoing Impavido
who become pregnant during treatment or within 5 months after completing treatment can
volunteer to provide information about their pregnancy and the outcome of the pregnancy.