Vaginal Estriol in Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Bladder Control Scale (BLCS) | 0.002 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- vaginal estriol
Results by group
Change in Bladder Control Scale (BLCS)
baseline and 9 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Urogenital Symptoms | -9 score on a scale | -11–-7 | 12 |
p = 0.002
Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes
Baseline and 9 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ocular Tomography | -4.4 millisecond | 10.4 (Standard Deviation) | 12 |
| Ocular Tomography | -10.7 millisecond | 14.4 (Standard Deviation) | 12 |
Ocular Tomography
Ocular Tomography
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Quality of Life Questionnaire | 14.87 score on a scale | 16.9 (Standard Deviation) | 12 |
| Quality of Life Questionnaire | 10.8 score on a scale | 17.8 (Standard Deviation) | 12 |
Quality of Life Questionnaire
Quality of Life Questionnaire
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | 12 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Bladder Control Scale (BLCS)
baseline and 9 months
Bladder, bowel and sexual functionChange in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes
Baseline and 9 months
Myelin repairChange 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
Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)
Who could take part
Relapsing MS · 40 to 65
Inclusion Criteria: 1. Female patients with RRMS over the age of 40 to 65. * Being prescribed vaginal estriol to treat their urogenital symptoms such as frequency, urgency, incontinence and frequent urinary tract infections. * Patients that had underwent chemical or surgical hysterectomy. 2. Patients will continue their current disease modifying agent for MS during the trial. Exclusion Criteria: 1. Patients with history of breast cancer, uterine or ovarian cancer. 2. Patients with progressive multiple sclerosis 3. Patients who are unable to undergo an MRI 4. Males 5. Patient is already on vaginal or oral or transdermal estrogens 6. Pregnant or breast-feeding patients 7. Patient taking sex hormones eg testosterone for libido 8. Patients taking DHEA or OTC related products that could influence the hormonal milieu. 9. Patient with prolapse uterus or conditions that would impact on transvaginal absorption of estriol
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Study to evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. The secondary objective is to evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.
Papers
Results
Avila-Ornelas J, Avila M, Stosic M, Robles L, Prieto PG, Hutton GJ, Rivera VM. The role of postpartum intravenous corticosteroids in the prevention of relapses in multiple sclerosis. Int J MS Care. 2011 Summer;13(2):91-3. doi: 10.7224/1537-2073-13.2.91.Results
Cody JD, Jacobs ML, Richardson K, Moehrer B, Hextall A. Oestrogen therapy for urinary incontinence in post-menopausal women. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD001405. doi: 10.1002/14651858.CD001405.pub3.Results
Harlow DE, Honce JM, Miravalle AA. Remyelination Therapy in Multiple Sclerosis. Front Neurol. 2015 Dec 10;6:257. doi: 10.3389/fneur.2015.00257. eCollection 2015.Results
Mallik S, Samson RS, Wheeler-Kingshott CA, Miller DH. Imaging outcomes for trials of remyelination in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2014 Dec;85(12):1396-404. doi: 10.1136/jnnp-2014-307650. Epub 2014 Apr 25.Results
Moore KH. The costs of urinary incontinence. Med J Aust. 2001 May 7;174(9):436-7. doi: 10.5694/j.1326-5377.2001.tb143368.x. No abstract available.Results
Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1147-1156. doi: 10.1097/AOG.0000000000000526.Results
Tiwari-Woodruff S, Voskuhl RR. Neuroprotective and anti-inflammatory effects of estrogen receptor ligand treatment in mice. J Neurol Sci. 2009 Nov 15;286(1-2):81-5. doi: 10.1016/j.jns.2009.04.023. Epub 2009 May 13.
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History
Started
Jun 2019
Main results due
Nov 2020
Finished
Nov 2020
Results posted
Sept 2022
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