Menopause Clinical Trial
Official title:
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
This study is the second clinical trial to be conducted by the Menopause Strategies -
Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, a group of
investigators conducting clinical trials designed to find new ways to alleviate the most
common, bothersome symptoms of the menopausal transition.
In this twelve-week clinical trial, 374 women aged 40-62 who are in the late menopausal
transition or postmenopausal and experiencing bothersome hot flashes will be randomized to
one of three behavioral intervention groups: yoga, exercise, or usual activity. All women
will simultaneously be randomized to receive omega-3 supplementation or a matching placebo.
The primary aims of this trial are to compare the magnitude of changes in perceived,
self-reported frequency and bother of vasomotor symptoms (VMS) before and after the
intervention between yoga and the usual activity comparison group, between exercise and the
usual activity comparison group, and between omega-3 fatty acid supplementation or placebo.
The hypotheses to be tested are:
1. Women assigned to yoga will report lower frequency and less VMS bother than women
assigned to the usual activity group at the end of a 12-week study period.
2. Women assigned to aerobic exercise at moderate-vigorous intensity will report lower
frequency and less VMS bother than women assigned to the usual activity group at the
end of a 12-week study period.
3. Women assigned to omega-3 fatty acid supplementation will report lower frequency and
less VMS bother than women assigned to the placebo group at the end of a 12-week study
period.
The omega-3 component of the study is double-blinded. For yoga, exercise, and usual
activity, the outcomes assessors are blinded to the randomization assignments.
Over 33 million U.S. women will transition through menopause in the next decade. Among women
with natural menopause, the transition typically lasts four years, with a mean age at
menopause of 51 years. Menstrual irregularity (90%) and vasomotor symptoms (VMS) (80%) are
the most common symptoms associated with the transition. Hormone therapy has been the gold
standard for treating VMS symptoms against which other therapies are measured. However,
resistance to hormone therapy use due to its risks and side effects continues to fuel the
search for safer alternatives.
This research study will evaluate three low risk interventions (yoga, exercise, and omega-3
supplements) compared to either a usual activity group or a placebo pill. This factorial
design is motivated by the desire to have all women receive some intervention. Neither
comparisons between yoga and exercise nor tests of interaction between the behavioral
interventions (yoga, exercise, usual activity) and omega-3 motivated this design. However,
these aspects can be examined in secondary analyses in a more rigorous fashion through this
design than would be permitted by separate trials.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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