NCT02431429

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

April 22, 2015

Last Update Submit

February 28, 2019

Conditions

Mucocutaneous Leishmaniasis

Keywords

leishmaniasismiltefosinespermiogram

Outcome Measures

Primary Outcomes (1)

  • number of patients with abnormal spermiogram

    4 weeks of therapy plus up to 3-6 months after therapy

Secondary Outcomes (1)

  • number of patients with abnormal values of testosterone/FSH

    4 weeks of theapy plus up to 3-6 months after therapy

Study Arms (1)

miltefosine

miltefosine: target of 2.5 mg/kg/day for 28 days

Drug: Miltefosine

Interventions

MiltefosineDRUG
miltefosine

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

mucocutaneous leishmaniasis patients

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Funderama

Santa Cruz, Bolivia

Location

MeSH Terms

Conditions

Leishmaniasis, MucocutaneousLeishmaniasis

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Leishmaniasis, CutaneousEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jaime Soto, MD

    Fundacion Nacional de Dermatologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 1, 2015

Study Start

July 1, 2015

Primary Completion

February 23, 2018

Study Completion

March 1, 2019

Last Updated

March 4, 2019

Record last verified: 2018-03

Locations

BO(1)