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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02431429 |
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Date of registration:
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22/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
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Scientific title:
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Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02431429 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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Jaime Soto, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundacion Nacional de Dermatologia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Mucocutaneous Leishmaniasis
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Intervention(s)
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Drug: Miltefosine
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Primary Outcome(s)
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number of patients with abnormal spermiogram
[Time Frame: 4 weeks of therapy plus up to 3-6 months after therapy]
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Secondary Outcome(s)
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number of patients with abnormal values of testosterone/FSH
[Time Frame: 4 weeks of theapy plus up to 3-6 months after therapy]
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Secondary ID(s)
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MILT 2127-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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