A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Safety, Tolerability, and Effectiveness of a Tissues Selective Estrogen Complex in Managing Menopausal Symptoms in Women with Multiple Sclerosis.
This Phase II clinical trial will assess the efficacy, safety, and tolerability of bazedoxifene+conjugated estrogens, a Tissue-Selective Estrogen Complex, in patients with relapsing-remitting multiple sclerosis. This drug was approved for the treatment of menopausal symptoms by the Food and Drug Administration (FDA). However, it has not been examined specifically in women with multiple sclerosis.
Study participants will be asked to come to the UCSF MS Research Center for a screening visit, and then 2 study visits: at baseline and 2 months. All study visits will occur at the UCSF campus. Most visits will take about 2 hours. A subset of participants will also undergo an MRI at baseline and at 2 months.
Study participation will involve taking the study drug by mouth, once each day, or the equivalent amount of placebo. Participants will be randomized into one of two groups: the drug group, or the placebo group. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot take any other hormonal therapies.