Multiple SclerosisPhase 2/3NCT03774407
Vaginal Estriol in Multiple Sclerosis
A Phase 2/3 study testing vaginal estriol in people with Multiple Sclerosis and Neurogenic Bladder, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Multiple Sclerosis, Neurogenic Bladder
- What is being tested?
- vaginal estriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 29 Nov 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)
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.
Read the 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 department of Texas Tech University Health Sciences Center. This study has been planned in collaboration with reproductive endocrinology, endocrinology, gynecology and basic science. The 1mg transvaginal dose was chosen after careful search of the literature and consultation with collaborators.
Single-group pilot study.
Subjects:
Patients with relapsing remitting MS and urogenital symptoms (frequency, urgency, frequent urinary tract infections, incontinence) will be invited to participate in the study. Enrollment will be during their scheduled clinic appointment. Some candidates (patients of the primary investigator) may be contacted by phone and invited to participate in the study.
The clinical trial will be explained to potential participants in detail, reviewing the objectives and methodology of the study. There will be adequate time allotted to answer any questions or concerns from the potential participants. Those patients interested in participating in the study will be asked to sign the consent form. In order to remind patients about their follow-up visits, lab work, etc., they will be contacted routinely. Participants will be instructed to call in case of questions or concerns.
Patients will be evaluated clinically during their scheduled follow up in which a full neurological exam will be performed during each visit. Patients will be instructed by the primary investigator how to correctly use the vaginal cream. This will be done at their enrolment and reinforced by the principal investigator, during their follow up visits.
- Conditions
- Multiple Sclerosis, Neurogenic Bladder
- Being tested
- vaginal estriol
- Keywords
- remyelination, urogenital health, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal estriolDrug
Also called estriol cream
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.
| Study group | Role | What they receive |
|---|---|---|
| urogenital symptoms | Other | To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. Receives: Drug: vaginal estriol |
| remyelination | Experimental | To evaluate the potential role of vaginal estriol in re-myelination in RRMS patients. Receives: Drug: vaginal estriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Quality of life score at baseline and Quality of life score at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start20 Jun 2019
- Primary completion10 Nov 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirla Avila, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774407
- Sponsor's protocol ID
- L19-020
- Status last verified
- Aug 2022
- First submitted
- 5 Dec 2018
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24453710Cody 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.
PubMed 23076892Harlow 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.
PubMed 26696956Mallik 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.
PubMed 24769473Moore 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.
PubMed 11386586Rahn 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.
PubMed 25415166Tiwari-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.
PubMed 19442988
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS)
- ClinicalTrials.gov ID
- NCT03774407
- Acronym / sponsor ID
- L19-020
- Conditions
- Multiple Sclerosis, Neurogenic Bladder
- Keywords
- remyelination, urogenital health, multiple sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 department of Texas Tech University Health Sciences Center. This study has been planned in collaboration with reproductive endocrinology, endocrinology, gynecology and basic science. The 1mg transvaginal dose was chosen after careful search of the literature and consultation with collaborators.
Single-group pilot study.
Subjects:
Patients with relapsing remitting MS and urogenital symptoms (frequency, urgency, frequent urinary tract infections, incontinence) will be invited to participate in the study. Enrollment will be during their scheduled clinic appointment. Some candidates (patients of the primary investigator) may be contacted by phone and invited to participate in the study.
The clinical trial will be explained to potential participants in detail, reviewing the objectives and methodology of the study. There will be adequate time allotted to answer any questions or concerns from the potential participants. Those patients interested in participating in the study will be asked to sign the consent form. In order to remind patients about their follow-up visits, lab work, etc., they will be contacted routinely. Participants will be instructed to call in case of questions or concerns.
Patients will be evaluated clinically during their scheduled follow up in which a full neurological exam will be performed during each visit. Patients will be instructed by the primary investigator how to correctly use the vaginal cream. This will be done at their enrolment and reinforced by the principal investigator, during their follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,
| Arm | Type | Receives |
|---|---|---|
| urogenital symptoms | Other | Drug: vaginal estriolTo evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. |
| remyelination | Experimental | Drug: vaginal estriolTo evaluate the potential role of vaginal estriol in re-myelination in RRMS patients. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients with RRMS over the age of 40 to 65.
- Patients will continue their current disease modifying agent for MS during the trial.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal estriolAlso: estriol creamEstriol 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. | Drug | remyelination, urogenital symptoms |
Primary outcome
Change in Bladder Control Scale (BLCS)
Time frame: 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.
Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes
Time frame: Baseline and 9 months
visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds
Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24453710Avila-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.
- Results publication: PubMed 23076892Cody 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.
- Results publication: PubMed 26696956Harlow 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.
- Results publication: PubMed 24769473Mallik 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.
- Results publication: PubMed 11386586Moore 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.
- Results publication: PubMed 25415166Rahn 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.
- Results publication: PubMed 19442988Tiwari-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirla Avila principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vaginal estriol in people with Multiple Sclerosis and Neurogenic Bladder, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bladder Control Scale (BLCS) (time frame: baseline and 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774407, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.