Summary: Investigators in California, Colorado, New Mexico and Pennsylvania are recruiting 64 women with MS relapsing-remitting, secondary-progressive, or primary-progressive for a 12-month study in which the sex hormone estriol will be compared with inactive placebo for effects on cognitive function. Participants can remain on their prescribed MS medication throughout the study. Rhonda Voskuhl, MD (University of California at Los Angeles) is the principal investigator of the trial. The study is funded by various private donors to the UCLA program.
Rationale: Estriol levels rise to very high levels naturally during late pregnancy, a time when most women’s MS disease activity declines. This led some to suspect that estriol may be responsible for this easing of symptoms during pregnancy. Dr. Rhonda Voskuhl (University of California, Los Angeles) and others showed that in mice estriol treatment was indeed protective. They then explored this lead with Society support, showing that estriol decreased disease activity in a small, early-phase trial of estriol in 12 women with MS. The National MS Society funded a team of investigators at 15 medical centers to conduct a two-year, controlled clinical trial of estriol added to standard therapy to treat MS. This trial recently reported results.
Meanwhile, Dr. Voskuhl’s team also has shown that, in mice, treatment with estrogen (a hormone related to estriol) can improve nerve impulse transmission in an area of the brain related to learning and memory, called the hippocampus. Problems with learning, memory and other cognitive functions are common in MS. (Laboratory Investigation 2012;92:1234) These and other observations led to the launch of this clinical trial to test the ability of estriol to improve cognition in women with MS.
Eligibility and Details: The researchers are seeking volunteers who are women 18 to 50 who have been diagnosed with relapsing-remitting, secondary-progressive, or primary-progressive MS. If participants are on standard MS treatments, they may remain on these medications during the study. Participants should not have had a relapse within 30 days before the day of trial enrollment. A cognitive test called the Paced Auditory Serial Addition Test (PASAT) will be administered to determine whether the participant qualifies for the study. Participants are excluded if they are on oral contraceptives, hormone replacement therapy, progesterone IUDs or other sex hormones during screening and during the 12-month study period. For more details about enrollment criteria, please contact the site nearest you (listed below).
Participants are being randomly assigned to receive oral estrogen (8mg/day) or inactive placebo for one year. The primary outcome is improvement in cognitive function as measured by PASAT scores. Secondary outcomes under study include measurements from brain MRIs, cognition, quality of life, depression, and fatigue.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact (for information about all sites nationwide):
University of California, Los Angeles
Contact: Jenny Bardens
Phone: (310) 206-2176
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).