Clinical trial NCT03774407: Vaginal Estriol in Multiple Sclerosis
Official title: Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Neurogenic Bladder
Keywords: remyelination
urogenital health
multiple sclerosis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 21
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,
Primary purpose: TREATMENT

Brief 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.

Detailed description: Pilot project to determine the effectiveness of 1 mg transvaginal estriol, as an adjunctive therapy for female MS patients. The goal is to recruit 20 patients from the MS clinic in the neurology department of Texas Tech University Health Sciences Center. This study has been planned in collaboration with reproductive endocrinology, endocrinology, gynecology and basic science. The 1mg transvaginal dose was chosen after careful search of the literature and consultation with collaborators.

Single-group pilot study.

Subjects:

Patients with relapsing remitting MS and urogenital symptoms (frequency, urgency, frequent urinary tract infections, incontinence) will be invited to participate in the study. Enrollment will be during their scheduled clinic appointment. Some candidates (patients of the primary investigator) may be contacted by phone and invited to participate in the study.

The clinical trial will be explained to potential participants in detail, reviewing the objectives and methodology of the study. There will be adequate time allotted to answer any questions or concerns from the potential participants. Those patients interested in participating in the study will be asked to sign the consent form. In order to remind patients about their follow-up visits, lab work, etc., they will be contacted routinely. Participants will be instructed to call in case of questions or concerns.

Patients will be evaluated clinically during their scheduled follow up in which a full neurological exam will be performed during each visit. Patients will be instructed by the primary investigator how to correctly use the vaginal cream. This will be done at their enrolment and reinforced by the principal investigator, during their follow up visits.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Bladder Control Scale (BLCS)
timeFrame: baseline and 9 months
measure: Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes
timeFrame: Baseline and 9 months
measure: Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score)
timeFrame: Quality of life score at baseline and Quality of life score at 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University
name: Mirla Avila
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.