NCT02679885CompletedNot Applicable
Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Griffin Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Serum levels of teriflunomide in males and their female partners
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Serum levels of teriflunomide in males and their female partners
Time Frame: Up to one year
single laboratory evaluation
Secondary Outcomes
No secondary outcomes reported
Investigators
Joseph B. Guarnaccia
Director
Griffin Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple SclerosisMultiple Sclerosis, PharmacokineticsNCT04129736Jan Lycke12
Completed
Phase 4
MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCVMultiple SclerosisNCT01970410Providence Health & Services55
Completed
Phase 4
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisNCT03856619Sanofi121
Active, not recruiting
Not Applicable
Effect of Teriflunomide Treatment on Microglial Activation in an MS Patient Cohort at Risk of ProgressionMultiple SclerosisNCT03368677Turku University Hospital26
Completed
Phase 3
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple SclerosisMultiple SclerosisNCT00134563Sanofi1,088