Teriflunomide Male Transmission Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/3/2019 |
| Start Date: | October 2015 |
| End Date: | September 2018 |
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.
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.
A total of 10 couples were enrolled in the study. Females partners had undetectable or
borderline levels of teriflunomide.
borderline levels of teriflunomide.
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.
We found this trial at
1
site
Derby, Connecticut 06418
Phone: 203-732-1290
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