Trial Outcomes & Findings for Vaginal Estriol in Multiple Sclerosis (NCT NCT03774407)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

21 participants

Primary outcome timeframe

baseline and 9 months

Results posted on

2022-09-21

Participant Flow

one participant was enrolled twice

Participant milestones

Participant milestones
Measure	Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination Pilot study at TTUHSC department of neurology, MS clinic. Adjunctive vaginal estriol (1mg) was offered to patient with RRMS. MRI brain with and without contrast, VEP and OCT obtained at baseline and 9 months. Multiple sclerosis quality of life-54(MSQOL-54) mental and physical were performed at first encounter and 9 months. Vaginal estriol is absorbed more naturally, levels of FSH, estriol and LH were done at baseline and 9 months. Total 12 patients included.
Overall Study STARTED	21
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination n=12 Participants To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. 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.
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	52 years STANDARD_DEVIATION 6.9 • n=12 Participants
Sex: Female, Male Female	12 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants

PRIMARY outcome

Timeframe: baseline and 9 months

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.

Outcome measures

Outcome measures
Measure	Urogenital Symptoms n=12 Participants Evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. 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.
Change in Bladder Control Scale (BLCS)	-9 score on a scale Interval -11.0 to -7.0

PRIMARY outcome

Timeframe: Baseline and 9 months

Population: patients were evaluated at baseline and 9 months

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

Outcome measures

Outcome measures
Measure	Urogenital Symptoms n=12 Participants Evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. 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.
Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes R EYE	-4.4 millisecond Standard Deviation 10.4
Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes L EYE	-10.7 millisecond Standard Deviation 14.4

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Urogenital Symptoms n=12 Participants Evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. 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.
Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) Quality of life Physical score	14.87 score on a scale Standard Deviation 16.9
Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) Quality of life Mental score	10.8 score on a scale Standard Deviation 17.8

Adverse Events

Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mirla Avila

Texas Tech

Phone: 8322448072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place