Teriflunomide Male Transmission Study
Completed
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02679885
- Run by
- Griffin Hospital
- People needed
- 20
- Starts
- 2015-10-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2019-01-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Multiple Sclerosis Treatment Center at Griffin Hospital — Derby, Connecticut, United States
Full record on ClinicalTrials.gov
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