Vaginal Estriol in Multiple Sclerosis

• Status: Completed
• Trial end date: 2020-11-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center

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