Vaginal Estriol in Multiple Sclerosis

Sponsor

Texas Tech University Health Sciences Center (Other)

Overall Status

Completed

CT.gov ID

NCT03774407

Collaborator

(none)

Enrollment

Location

Arms

17.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Neurogenic Bladder	Drug: vaginal estriol	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)

Actual Study Start Date :

Jun 20, 2019

Actual Primary Completion Date :

Nov 10, 2020

Actual Study Completion Date :

Nov 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: urogenital symptoms To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS.	Drug: vaginal estriol Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator. Other Names: estriol cream
Experimental: remyelination To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.	Drug: vaginal estriol Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator. Other Names: estriol cream

Arm

Intervention/Treatment

Other: urogenital symptoms

To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS.

Drug: vaginal estriol

Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator.

Other Names:

estriol cream

Experimental: remyelination

To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.

Drug: vaginal estriol

Other Names:

estriol cream

Outcome Measures

Primary Outcome Measures

To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. In order to evaluate urogenital changes after the use of estriol, patients will fill a bladder control scale at baseline, 3 and 9 months. [9 months]
Female patients with RRMS and urogenital symptoms (urgency, frequency, intermittent incontinence) that would like to participate, will be given a bladder control scale at baseline, 3 and 9 months after starting transvaginal estriol. The bladder control scale is a four-item questionnaire that provides a brief assessment of bladder control and the extent to which bladder problems have an impact on everyday activities. It is a self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. 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.
Patients will also fill a three day voiding questionnaire at baseline, 3 and 9 months. [9 months]
Female patients with RRMS and urogenital symptoms (urgency, frequency, intermittent incontinence) that would like to participate, will be given three day voiding questionnaire at baseline, 3 and 9 months after starting transvaginal estriol. This questionnaire has been validated to evaluate lower urinary tract symptoms and woman, it consists of a 3-day diary of the urinary symptoms. Patients have to record time of day which they went to bed and woke up and time of day of voiding. Also they record their fluid intake, there are toilet voids, the amount of urine in case this was drained by a catheter, leaks, number of pad changes if applicable.
Quality of life questionnaire at baseline, 3 and 9 months. [9 months]
Female patients with RRMS and urogenital symptoms (urgency, frequency, intermittent incontinence) that would like to participate, will be given a quality of life questionnaire will be given at baseline, 3 and 9 months after starting transvaginal estriol

Secondary Outcome Measures

To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with 3T MRI [9 months]
Assessment for evidence of re-myelination associated to the use of transvaginal estriol in woman with MS. Objective measurements for re-myelination will be quantified with brain MRI 3T at baseline and 9 months.
To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Optical coherence tomography (OCT) [6 months]
Assessment for evidence of re-myelination associated to the use of transvaginal estriol in woman with MS. Objective measurements for re-myelination will be quantified with Optical coherence tomography (OCT) at baseline, month 3 and month 6.
To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Visual evoked potentials. [6 months]
Assessment for evidence of re-myelination associated to the use of transvaginal estriol in woman with MS. Objective measurements for re-myelination will be quantified with Visual evoked potentials (VEP) at baseline, 3 and 6 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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