- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431429
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
February 28, 2019 updated by: Knight Therapeutics (USA) Inc
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santa Cruz, Bolivia
- Funderama
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
mucocutaneous leishmaniasis patients
Description
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
- Have not had a vasectomy and agree to not have a vasectomy for the duration of the study
- Have testosterone WNL (> 300 ng/dL) and FSH WNL (1.5 - 2.4 mIU/mL)
Have screening semen parameters (mean of both tests) of:
- semen volume at least 1.5 mL
- total sperm count greater than 45 million
- sperm concentration greater than 30 million/mL
- sperm motility greater than 50% (total percentage progressively motile sperm)
- normal sperm morphology by strict criteria >10%
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.
- Have history of surgical prostatectomy
- Have positive serology for Chagas Disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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miltefosine
miltefosine: target of 2.5 mg/kg/day for 28 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of patients with abnormal spermiogram
Time Frame: 4 weeks of therapy plus up to 3-6 months after therapy
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4 weeks of therapy plus up to 3-6 months after therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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4 weeks of theapy plus up to 3-6 months after therapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
February 23, 2018
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
April 22, 2015
First Submitted That Met QC Criteria
April 27, 2015
First Posted (Estimate)
May 1, 2015
Study Record Updates
Last Update Posted (Actual)
March 4, 2019
Last Update Submitted That Met QC Criteria
February 28, 2019
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis, Cutaneous
- Leishmaniasis
- Leishmaniasis, Mucocutaneous
- Anti-Infective Agents
- Antineoplastic Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Miltefosine
Other Study ID Numbers
- MILT 2127-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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