Multiple Sclerosis Clinical Trial

Teriflunomide Male Transmission Study

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.

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily;
Continuous treatment for three months with good compliance as assessed by the investigator
Age between 18 and 55
Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation.
Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert
Able to give informed consent

Females

Regular sexual intercourse with a male partner who is actively taking teriflunomide
Age between 18 and 55
Able to give informed consent
Negative urine pregnancy test at the time of blood sampling
Reliable contraception that does not involve barrier methods

Exclusion Criteria:

Use of barrier methods of contraception
For males, contraindications to the continued use of teriflunomide
Couples that are actively trying to conceive
For males, noncompliance with teriflunomide therapy
Inability or unwilling to give consent or comply with the protocol
Pregnancy of the female sexual partner.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

20

Study ID:

NCT02679885

Recruitment Status:

Completed

Sponsor:

Griffin Hospital

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There is 1 Location for this study

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Multiple Sclerosis Treatment Center at Griffin Hospital
Derby Connecticut, 06418, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

20

Study ID:

NCT02679885

Recruitment Status:

Completed

Sponsor:


Griffin Hospital

How clear is this clinincal trial information?

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