Clinical Trials Directory

Trials / Completed

CompletedNCT02679885

Teriflunomide Male Transmission Study

Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Griffin Hospital · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

Summary

It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.

Detailed description

A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.

Conditions

Timeline

Start date
2015-10-01
Primary completion
2018-08-01
Completion
2018-09-01
First posted
2016-02-10
Last updated
2019-01-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02679885. Inclusion in this directory is not an endorsement.