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The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis (Tysex)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01455220
First received: October 10, 2011
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: May 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Supportive Care
Condition: Multiple Sclerosis
Intervention: Drug: Tysabri ® (Natalizumab)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Patients No text entered.

Participant Flow:   Overall Study
    All Patients
STARTED   45 
COMPLETED   15 
NOT COMPLETED   30 
screen fail                30 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Tysabri All patients were receiving commercial Tysabri

Baseline Measures
   Tysabri 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  73.3% 
Male      4  26.7% 


  Outcome Measures
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1.  Primary:   Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )   [ Time Frame: Baseline, 6 months ]

2.  Secondary:   Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))   [ Time Frame: Baseline, 6 months ]

3.  Secondary:   Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))   [ Time Frame: Baseline, 6 months ]

4.  Secondary:   Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr.Tuan Vu/ Dr. Derrick Robertson
Organization: University of South Florida
phone: 813-974-6378
e-mail: droberts@health.usf.edu



Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01455220     History of Changes
Other Study ID Numbers: US-TYS-10-10057
Study First Received: October 10, 2011
Results First Received: May 10, 2016
Last Updated: February 14, 2017