Status:
COMPLETED
Vaginal Estriol in Multiple Sclerosis
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Multiple Sclerosis
Neurogenic Bladder
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
PHASE3
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 i...
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 depar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03774407
Start Date
June 20 2019
End Date
November 29 2020
Last Update
September 21 2022
Active Locations (1)
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1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430