Trial · NCT03774407
Vaginal Estriol in Multiple Sclerosis
NCT03774407, Phase 2, Phase 3, Completed, Texas Tech University Health Sciences Center; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaginal Estriol in Multiple Sclerosis. Trials, record NCT03774407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03774407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaginal Estriol in Multiple Sclerosis
- NCT number
- NCT03774407
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Texas Tech University Health Sciences Center
- Conditions
- Multiple Sclerosis, Neurogenic Bladder
- Interventions
- vaginal estriol
- First posted
- 2018-12-13
- Last updated
- 2022-09-21
- Results first posted
- 2022-09-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bladder Control Scale (BLCS) | baseline and 9 months | The questions are regarding control of the bladder, number of accidents in the past 4 weeks, alteration of activities because of bladder problems and restriction on lifestyle because of bladder problems. The total score for the BLCS is the sum of the scores for the 4 items. Scores can range from 0-22, with higher scores indicating greater bladder control problems. Change from baseline at 9 months. |
| Primary | Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | Baseline and 9 months | visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds |
| Primary | Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of life score at baseline and Quality of life score at 9 months | Multiple sclerosis quality of life questionnaire is an extensive questionnaire filled by the patient and graded by physician. It consists of 2 main areas the physical health which include physical function, health perceptions, energy fatigue, role limitations, pain, sexual function, social function and health distress. The mental health score which includes health distress, overall quality of life, emotional wellbeing, role limitations and cognitive function. The physical health and mental health parts each include a possible score range of 0-100. Overall the lower the score the better |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Bladder Control Scale (BLCS) | baseline and 9 months | score on a scale | MEDIAN | |
| PRIMARY | Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | Baseline and 9 months | patients were evaluated at baseline and 9 months | millisecond | MEAN |
| PRIMARY | Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of life score at baseline and Quality of life score at 9 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bladder Control Scale (BLCS) | Urogenital Symptoms | -9 | Inter-Quartile Range -11 to -7 | score on a scale | |
| Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | Ocular Tomography | R EYE | -4.4 | Standard Deviation 10.4 | millisecond |
| Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | Ocular Tomography | L EYE | -10.7 | Standard Deviation 14.4 | millisecond |
| Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of Life Questionnaire | Quality of life Physical score | 14.87 | Standard Deviation 16.9 | score on a scale |
| Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of Life Questionnaire | Quality of life Mental score | 10.8 | Standard Deviation 17.8 | score 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 | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 21 | |
| Overall Study | COMPLETED | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 12 | |
| Overall Study | NOT COMPLETED | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 9 |
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 | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 0 | 12 |
| Total, other adverse events | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 0 | 12 |
| Total, serious adverse events | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 0 | 12 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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/NCT03774407
GET https://conductscience.org/api/trials/v1/NCT03774407/registered