Teriflunomide Male Transmission Study

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will include approximately twenty heterosexual couples. The male partner will be a subject who has been taking teriflunomide as part of his multiple sclerosis treatment for at least three months and engaging in active sexual relations with his female spouse or partner.

Description

Inclusion Criteria:

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

Females

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum levels of teriflunomide in males and their female partners	single laboratory evaluation	Up to one year

Collaborators and Investigators

• Sponsor: Griffin Hospital
• Investigators: Principal Investigator: Joseph Guarnaccia, MD, MSTC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 29, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: TERI001