Vaginal Estriol in Multiple Sclerosis

NCT03774407 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: L19-020
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Neurogenic Bladder

Keywords

remyelination; urogenital health; multiple sclerosis

Outcome Measures

Primary Outcomes (3)

• Change in Bladder Control Scale (BLCS)

  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. Change from baseline at 9 months.

  baseline and 9 months

• Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes

  visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds

  Baseline and 9 months

• Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score)

  Multiple sclerosis quality of life questionnaire is an extensive questionnaire filled by the patient and graded by physician. It consists of 2 main areas the physical health which include physical function, health perceptions, energy fatigue, role limitations, pain, sexual function, social function and health distress. The mental health score which includes health distress, overall quality of life, emotional wellbeing, role limitations and cognitive function. The physical health and mental health parts each include a possible score range of 0-100. Overall the lower the score the better

  Quality of life score at baseline and Quality of life score at 9 months

Study Arms (2)

urogenital symptoms

OTHER

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

Drug: vaginal estriol

remyelination

EXPERIMENTAL

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

Drug: vaginal estriol

Interventions

vaginal estriol 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.

Also known as: estriol cream

remyelination; urogenital symptoms

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (7)

• 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.

  PMID: 24453710 RESULT

• 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.

  PMID: 23076892 RESULT

• 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.

  PMID: 26696956 RESULT

• 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.

  PMID: 24769473 RESULT

• 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.

  PMID: 11386586 RESULT

• 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.

  PMID: 25415166 RESULT

• 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.

  PMID: 19442988 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Mirla Avila
• Organization: Texas Tech

mirla.avila@ttuhsc.edu

8322448072

Study Officials

• Mirla Avila

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 13, 2018
• Study Start: June 20, 2019
• Primary Completion: November 10, 2020
• Study Completion: November 29, 2020
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)