Trial · NCT01455220
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
NCT01455220, Not applicable, Completed, University of South Florida; results first posted 2017-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis. Trials, record NCT01455220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01455220
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
- NCT number
- NCT01455220
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- Multiple Sclerosis
- Interventions
- Tysabri ® (Natalizumab)
- First posted
- 2011-10-19
- Last updated
- 2017-03-31
- Results first posted
- 2017-03-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Baseline, 6 months | Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score. |
| Secondary | Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction). |
| Secondary | Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | Baseline, 6 months | Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality. |
| Secondary | Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Baseline, 6 months | units on a scale | MEAN | |
| SECONDARY | Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | units on a scale | MEAN | |
| SECONDARY | Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | Baseline, 6 months | units on a scale | MEAN | |
| SECONDARY | Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Baseline to 6 Months (MSISQ-19 Scores) | -0.697 | Standard Deviation 0.29 | units on a scale | |
| Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | MSQOL-54, Physical (Baseline to 6 Months) | 0.29 | Standard Deviation 0.67 | units on a scale | |
| Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | FAMS (Baseline to 6 Months) | 2.57 | Standard Deviation 0.99 | units on a scale | |
| Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | MSQOL-54 Total (Baseline to 6 Months) | 0.73 | Standard Deviation 0.71 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients | 45 | |
| Overall Study | COMPLETED | All Patients | 15 | |
| Overall Study | NOT COMPLETED | All Patients | 30 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 0 | 15 |
| Total, serious adverse events | All Patients | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01455220
GET https://conductscience.org/api/trials/v1/NCT01455220/registered