Vaginal Estriol in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT03774407
• Date of registration: 05/12/2018
• Prospective Registration: Yes
• Primary sponsor: Texas Tech University Health Sciences Center
• Public title: Vaginal Estriol in Multiple Sclerosis
• Scientific title: Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)
• Date of first enrolment: June 20, 2019
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03774407
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Neurogenic Bladder

Multiple Sclerosis

Intervention(s)

Drug: vaginal estriol

Primary Outcome(s)

Quality of life questionnaire at baseline, 3 and 9 months. [Time Frame: 9 months]

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

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]

Secondary Outcome(s)

To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Visual evoked potentials. [Time Frame: 6 months]

To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with 3T MRI [Time Frame: 9 months]

To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients with Optical coherence tomography (OCT) [Time Frame: 6 months]

Secondary ID(s)

L19-020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors