Vaginal Estriol in Multiple Sclerosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2020-11-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis Neurogenic Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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urogenital symptoms

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

Group Type OTHER

vaginal estriol

Intervention Type DRUG

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.

remyelination

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

Group Type EXPERIMENTAL

vaginal estriol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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estriol cream

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No