Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis

This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide semen samples for spermiogram analysis of sperm parameters. Potential subjects diagnosed with mucocutaneous leishmaniasis who are planning to undergo miltefosine treatment will be informed about the study and undergo the informed consent process. After obtaining informed consent, subjects will be screened over a 28-day period for eligibility by medical history including leishmaniasis diagnostics, physical examination, clinical laboratory measurements [chemistries: (ALT, total bilirubin, creatinine; hematology: WBC count, hemoglobin, platelet count; spermiogram: sperm concentration, total sperm count, semen volume, sperm motility, and sperm morphology; hormones: testosterone and FSH]; and medication use in the 28-day period before starting treatment. If eligible for the study, the subject will receive miltefosine for 28 days at a target dose of approximately 2.5 mg/kg/day. Screening and enrollment into the study will continue until at least 55 subjects complete the study and are considered evaluable (provide sperm samples per protocol and complete at least 25 of 28 days of miltefosine treatment). Chemistries and hematology will be repeated at study Days 14 (mid-treatment) and 28 (end of treatment). Two semen samples will be collected during screening (at least 48 hours apart), at the end of treatment (Days 25-and-28), at 3-months after completing treatment. If clinically significant changes spermiogram findings are observed at 3 months, one sample will be collected at 6 months. Adverse events (AEs) and concomitant medication use will be collected during treatment. Concomitant medication use will also be collected at the 3-month visit and in any subject coming back for the 6-month visit. A medical history will be taken at the 3-month and 6-month (if conducted) focusing on any changes to the urogenital system.