Multiple Sclerosis
Conditions
Brief 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.
Interventions
None listed
Sponsors
Griffin Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of teriflunomide in males and their female partners | Up to one year | single laboratory evaluation |
Countries
United States
Outcome results
None listed