Phase 3
Completed N=21
Vaginal Estriol in Multiple Sclerosis
Multiple Sclerosis · Neurogenic Bladder
Source: ClinicalTrials.gov NCT03774407 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Change in Bladder Control Scale (BLCS) — -9 score on a scale — p=0.002
◆ Published Evidence
Highly cited
384citations · ~27 / year
Oestrogen therapy for urinary incontinence in post-menopausal women.
Summary
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.
Linked Publications (5)
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Oestrogen therapy for urinary incontinence in post-menopausal women.
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Imaging outcomes for trials of remyelination in multiple sclerosis.
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Remyelination Therapy in Multiple Sclerosis.
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The role of postpartum intravenous corticosteroids in the prevention of relapses in multiple sclerosis.
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The costs of urinary incontinence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bladder Control Scale (BLCS) |
-9 | 0.002 sig |
| PRIMARY Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes |
-4.4; -10.7 | — |
| PRIMARY Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) |
14.87; 10.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Patients will continue their current disease modifying agent for MS during the trial.
Exclusion Criteria
- Patients with history of breast cancer, uterine or ovarian cancer.
- Patients with progressive multiple sclerosis
- Patients who are unable to undergo an MRI
- Males
- Patient is already on vaginal or oral or transdermal estrogens
- Pregnant or breast-feeding patients
- Patient taking sex hormones eg testosterone for libido
- Patients taking DHEA or OTC related products that could influence the hormonal milieu.
- Patient with prolapse uterus or conditions that would impact on transvaginal absorption of estriol
Data sourced from ClinicalTrials.gov (NCT03774407) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.