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Teriflunomide Male Transmission Study

This study is currently recruiting participants.
Verified February 2017 by Joseph B. Guarnaccia, Griffin Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02679885
First Posted: February 10, 2016
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph B. Guarnaccia, Griffin Hospital
  Purpose
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.

Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners

Resource links provided by NLM:


Further study details as provided by Joseph B. Guarnaccia, Griffin Hospital:

Primary Outcome Measures:
  • Serum levels of teriflunomide in males and their female partners [ Time Frame: Up to one year ]
    single laboratory evaluation


Biospecimen Retention:   Samples Without DNA
Serum samples

Estimated Enrollment: 40
Study Start Date: October 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679885


Contacts
Contact: Joseph Guarnaccia, MD 203-732-1290 mstreatmentcenters@griffinhealth.org

Locations
United States, Connecticut
Multiple Sclerosis Treatment Center at Griffin Hospital Recruiting
Derby, Connecticut, United States, 06418
Contact: Joseph Guarnaccia, MD    203-732-1290    mstreatmentcenters@griffinhealth.org   
Sponsors and Collaborators
Griffin Hospital
  More Information

Responsible Party: Joseph B. Guarnaccia, Director, Griffin Hospital
ClinicalTrials.gov Identifier: NCT02679885     History of Changes
Other Study ID Numbers: TERI001
First Submitted: February 2, 2016
First Posted: February 10, 2016
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases