Teriflunomide Male Transmission Study

NCT02679885 | Completed

• 1 other identifier: TERI001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Serum levels of teriflunomide in males and their female partners

  single laboratory evaluation

  Up to one year

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will include approximately twenty heterosexual couples. The male partner will be a subject who has been taking teriflunomide as part of his multiple sclerosis treatment for at least three months and engaging in active sexual relations with his female spouse or partner.

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.

Sponsors & Collaborators

• Griffin Hospital: lead

Study Sites (1)

Multiple Sclerosis Treatment Center at Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joseph Guarnaccia, MD

  MSTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 10, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

US (1)