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Completed

NCT Number: NCT02679885

Teriflunomide Male Transmission Study

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Sclerosis Treatment Center at Griffin Hospital

Derby, Connecticut, 06418, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum levels of teriflunomide in males and their female partners

    Time frame: Up to one year

    single laboratory evaluation

Sponsors and collaborators

Lead sponsor

Griffin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 10, 2016
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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