Clinical TrialID 5601
Vaginal Estriol in Multiple Sclerosis
NCT03774407
Multiple Sclerosis|Neurogenic Bladder
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5601
- Evidence Id
- 5601
- Core Evidence Id
- 5601
- Source Clinical Trial Id
- 5586
- Herb2 Clinical Trial Id
- HBCT005586
- Nct Id
- NCT03774407
- Title
- Vaginal Estriol in Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 2|Phase 3
- Study Result
- Yes
- Study Condition
- Multiple Sclerosis|Neurogenic Bladder
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: vaginal estriol
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 21
- Outcome Measure
- Change in Bladder Control Scale (BLCS), 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., baseline and 9 months|Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes, visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds, Baseline and 9 months|Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score), 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, Quality of life score at baseline and Quality of life score at 9 months
- Sponsor Collaborator
- Texas Tech University Health Sciences Center
- Funded By
- OTHER
- Location
- Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States
- Other Id
- L19-020
- Start Date
- 2019-06-20
- Primary Completion Date
- 2020-11-10
- Completion Date
- 2020-11-29
- First Posted
- 2018-12-13
- Results First Posted
- 2022-09-21
- Last Update Posted
- 2022-09-21
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/07/NCT03774407/Prot_SAP_002.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/07/NCT03774407/ICF_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03774407
- Title Cn
- Title En
- Vaginal Estriol in Multiple Sclerosis
- Bilingual Status
- semi_complete