A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis (MS-TSEC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02710214|
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menopause Multiple Sclerosis||Drug: Tissue Selective Estrogen Complex Drug: Placebo||Phase 2|
Menopause in MS. Multiple sclerosis (MS) affects 3 times more women than men, and before age 50 in about 90% cases, i.e. prior to menopause. There is broad evidence for hormonal regulation of MS in animal models and in clinical cohorts. Around menopause, many clinical patients report symptom worsening associated with hot flashes, sleep disturbance or mood changes. Additionally, individuals at MS may be at increased risk of developing osteoporosis. Longer-term, an age-related decline in gonadal steroids might represent one sex-specific influence on the known age-related increases in disability and conversion to progressive course, which is marked by accelerated brain volume loss and neurodegeneration. Recent data suggest that MS disease severity may worsen after menopause.
- Hormone therapy (HT). Despite the benefits of HT (menopausal symptoms, bone density), very few women (<30% of our cohort) are currently taking HT for menopausal symptoms; this is a result of risks such as (1) breast and endometrial cancer, and (2) stroke in older women in the Women's Health Initiative. Recent data on HT use in MS (Nurses Health Study) did not show any adverse effects on MS course, and women who used HT reported better physical function than women who did not (Bove et al, Neurology 2016).
- Study Drug: Duavee, a tissue selective estrogen complex (TSEC), combines conjugated estrogens (CE) with the selective estrogen receptor modulator (SERM) bazedoxifene (BZA). BZA offsets estrogenic stimulation of endometrial and breast tissue, and CE 0.45mg/BZA 20mg is approved for menopausal symptom (hot flash) relief and osteoporosis prevention, with a favorable tolerability and safety profile.
In the current study, 24 women with MS and who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 8 weeks of Duavee or 8 weeks of placebo. Visits will be: eligibility, baseline, and 2 month visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial.|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks
Drug: Tissue Selective Estrogen Complex
Once-daily dosing of Duavee for 8 weeks.
Placebo Comparator: Placebo
Placebo pill daily for 8 weeks.
Once-daily dosing of placebo for 8 weeks
- Menopausal symptoms improves in MS women [ Time Frame: 8 weeks ]By measuring the number of daily vasomotor symptoms (VMS) and sleep quality recorded in the patient diary, the investigstors will assess the success if the observed mean change in the treatment group is larger than the amount in the placebo group.
- Improvement in MS-related outcomes [ Time Frame: 8 weeks ]The outcomes will include MSQOL54 composite score (primary), measures of mood (CES-D), fatigue (MFIS), cognition (MSNQ), and bladder (MSQLI BLCS), and our primary outcome is the MSRS, a global score capturing patient impressions of MS severity across eight function domains, and in which the clinic population has shown good correlation with the EDSS.
- CE+BZA is tolerable in women with MS [ Time Frame: 8 weeks ]The primary measure will be the percentage of subjects reporting side effects on the Satisfaction Questionnaire for Medication (TSQM)(Atkinson et al., 2004), which is commonly used in MS treatment studies. The secondary measures will be number of missed doses, and the number of new or enhancing lesions on 8-week MRI, to verify that CE+BZA does not yield any marked changes in inflammatory activity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710214
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Riley M Bove, MD||Assistant Professor of Clinical Neurology|