Mucocutaneous LeishmaniasisNCT02431429
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
An observational study of Mucocutaneous Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in Bolivia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Mucocutaneous Leishmaniasis
- What is being tested?
- Miltefosine
- How many people
- 55 participants
- Where
- 1 siteBolivia
- Study dates
- Jul 2015to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: mucocutaneous leishmaniasis patients
Who may be able to join
- 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)
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- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mucocutaneous Leishmaniasis
- Being tested
- Miltefosine
- Keywords
- leishmaniasis, miltefosine, spermiogram
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
| Study group | Role | What they receive |
|---|---|---|
| miltefosine | miltefosine: target of 2.5 mg/kg/day for 28 days Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with abnormal spermiogram
Measured: 4 weeks of therapy plus up to 3-6 months after therapy
Secondary outcomes (1)
number of patients with abnormal values of testosterone/FSH
Measured: 4 weeks of theapy plus up to 3-6 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJul 2015
- Primary completion23 Feb 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucocutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Soto, MD, Principal investigator, Fundacion Nacional de Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431429
- Sponsor's protocol ID
- MILT 2127-2
- Status last verified
- Mar 2018
- First submitted
- 22 Apr 2015
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT02431429
- Acronym / sponsor ID
- MILT 2127-2
- Conditions
- Mucocutaneous Leishmaniasis
- Keywords
- leishmaniasis, miltefosine, spermiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Knight Therapeutics (USA) IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| miltefosine | – | Drug: Miltefosinemiltefosine: target of 2.5 mg/kg/day for 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- mucocutaneous leishmaniasis patients
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miltefosine | Drug | miltefosine |
Primary outcome
number of patients with abnormal spermiogram
Time frame: 4 weeks of therapy plus up to 3-6 months after therapy
1 secondary outcome
number of patients with abnormal values of testosterone/FSH
Time frame: 4 weeks of theapy plus up to 3-6 months after therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Soto, MD principal investigator
Fundacion Nacional de Dermatologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucocutaneous Leishmaniasis, run by Knight Therapeutics (USA) Inc at 1 site in Bolivia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with abnormal spermiogram (time frame: 4 weeks of therapy plus up to 3-6 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.