A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis (NCT02710214) | Clinical Trial Compass
CompletedPhase 2
A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis
United States24 participantsStarted 2016-02
Plain-language summary
Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo controlled pilot study, is to determine whether this medication alleviates menopausal symptoms in women with MS. The investigators will secondarily determine whether addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening inflammation.
Who can participate
Age range
18 Years – 62 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 40-62 years.
* Perimenopausal: 6 months of amenorrhea; women who had a bi-lateral oophorectomy; women without a uterus and who still have one or both ovaries, with FSH level \> 20 mIU/mL and estradiol ≤ 50 pg/mL; women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval; women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level \> 20 mIU/mL and estradiol ≤ 50 pg/mL
* Bothersome MS symptoms: Mean of two or more hot flashes/night sweats per 24 hrs; Hot flashes/night sweats rated as bothersome ('moderately' to 'a lot') and/or severe ('moderate' to 'severe') on 4 or more 12 hour (day/night) blocks of times
* In general good health (determined by medical history, blood pressure, and heart rate)
* No history of endometrial, ovarian, or breast cancer; No abnormal mammogram in the last 2 years; Absence of any current severe or unstable medical illness
MS considerations:
* If using psychotropic medications: no change in the past 3 months
* If on DMT, no change in past 6 months Normal vitamin D levels (20-50 ng/mL)
Exclusion Criteria:
* BMI \>35 kg/m2 as higher BMI may affect PK/PD
* Use of hormone therapy or hormonal contraceptives 2 months prior to enrollment
* Use of any prescribed therapy that is taken specifically for hot flashes in the past 1 month.
* Use of any over-the-counter or herbal therapies that are taken specifically for hot flas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hot Flash Related Daily Interference Scale (HFRDIS) Score
Timeframe: Baseline and 8 weeks
2
Change in Number of Participants Who Experienced a Reduction in Hot Flashes Per 24 Hours From Baseline to 8 Weeks
Timeframe: Baseline and 8 weeks
3
Change in Average Hot Flashes Per Day From Baseline to 8 Weeks
Timeframe: Baseline and 8 weeks
4
Number of Participants Reporting Side Effects on the Treatment Satisfaction Questionnaire for Medication (TSQM)
Timeframe: 8 weeks
5
Change in the Expanded Disability Status Scale (EDSS)