Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leis… (NCT02431429) | Clinical Trial Compass
CompletedNot Applicable
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Bolivia55 participantsStarted 2015-07
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion criteria
✓. Provide written informed consent.
✓. Be available to complete study procedures
✓. Have a diagnosis of mucocutaneous leishmaniasis confirmed by microscopy of a stained smear of a lesion sample, by culture of a lesion sample, or by polymerase chain reaction (PCR) of a lesion sample or by Montenegro skin test and be planning to undergo treatment with miltefosine
✓. Be male and 18-55 years of age
✓. Have ALT, total bilirubin, and creatinine \< 1.5 upper limit of normal (ULN)
✓. Have values of ions that might affect ECG (magnesium, calcium, potassium, sodium) within normal laboratory limits (WNL)
✓. Have WBC count, hemoglobin, and platelet count within 15% of normal laboratory limits (WNL)
✓. Have no known history of male sexual dysfunction
Exclusion criteria
✕. Have presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol
✕. Have evidence by history of psychotropic and central nervous system drugs (e.g., antidepressants, anti-epileptics), anti-hypertensives, calcium channel blockers, chemotherapy drugs, colchicine, therapeutic hormones, finasteride, sulfasalazine, use of nicotine containing products or urine toxicology test for marijuana (tetrahydrocannabinol) and cocaine.
What they're measuring
1
number of patients with abnormal spermiogram
Timeframe: 4 weeks of therapy plus up to 3-6 months after therapy