Teriflunomide Male Transmission Study

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679885
• Other study ID #: TERI001
• Status: Completed
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Griffin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Multiple Sclerosis Treatment Center at Griffin Hospital	Derby	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Griffin Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of teriflunomide in males and their female partners	single laboratory evaluation	Up to one year