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

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knight Therapeutics (USA) Inc
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

1. Provide written informed consent.

2. Be available to complete study procedures

3. 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

4. Be male and 18-55 years of age

5. Have ALT, total bilirubin, and creatinine < 1.5 upper limit of normal (ULN)

6. Have values of ions that might affect ECG (magnesium, calcium, potassium, sodium) within normal laboratory limits (WNL)

7. Have WBC count, hemoglobin, and platelet count within 15% of normal laboratory limits (WNL)

8. Have no known history of male sexual dysfunction

9. Have not had a vasectomy and agree to not have a vasectomy for the duration of the study

10. Have testosterone WNL (> 300 ng/dL) and FSH WNL (1.5 - 2.4 mIU/mL)

11. Have screening semen parameters (mean of both tests) of:

1. semen volume at least 1.5 mL

2. total sperm count greater than 45 million

3. sperm concentration greater than 30 million/mL

4. sperm motility greater than 50% (total percentage progressively motile sperm)

5. normal sperm morphology by strict criteria >10%

Exclusion Criteria:

1. 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

2. 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.

3. Have history of surgical prostatectomy

4. Have positive serology for Chagas Disease