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Vaginal Estriol in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774407
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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,
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 : June 20, 2019
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Estriol

Arm Intervention/treatment
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 Name: 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 Name: estriol cream




Primary Outcome Measures :
  1. 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. [ Time Frame: 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.


  2. Patients will also fill a three day voiding questionnaire at baseline, 3 and 9 months. [ Time Frame: 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.


  3. Quality of life questionnaire at baseline, 3 and 9 months. [ Time Frame: 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 :
  1. To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with 3T MRI [ Time Frame: 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.

  2. To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Optical coherence tomography (OCT) [ Time Frame: 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.

  3. To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Visual evoked potentials. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774407


Contacts
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Contact: Mirla Avila, MD 8322448072 mirla.avila@ttuhsc.edu
Contact: Smathorn Thakolwiboon, MD 3125390935 Smathorn.Thakolwiboon@ttuhsc.edu

Locations
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United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Mirla Arvila, MD    806-743-2391    mirla.arvila@ttuhsc.edu   
Sponsors and Collaborators
Texas Tech University Health Sciences Center
  Study Documents (Full-Text)

Documents provided by Texas Tech University Health Sciences Center:
Informed Consent Form  [PDF] May 6, 2019

Publications of Results:

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT03774407    
Other Study ID Numbers: L19-020
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Texas Tech University Health Sciences Center:
remyelination
urogenital health
multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Urinary Bladder, Neurogenic
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases