Menopausal Treatment Using Relaxation Exercises (MaTURE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Change in average daily frequency of hot flashes.
Study Overview
Brief Summary
Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in suppressing hot flashes, it is associated with increased risk for a variety of serious adverse effects. There is an urgent need for alternative treatments that are effective, safe, and easy to use. In this study, the investigators will compare two different types of behavioral relaxation therapies, paced respiration and music therapy, for treatment of menopausal hot flashes. Effects on frequency of hot flashes, other symptom and quality-of-life outcomes associated with hot flashes, and physiologic measures of sympathetic/parasympathetic activity will be examined.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 59 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in average daily frequency of hot flashes.
Time Frame: 4-Weeks and 12-Weeks
Secondary Outcomes
- Change in subjective severity of hot flashes.(4-weeks and 12-weeks)
- Change in sympathetic and parasympathetic autonomic nervous system tone.(12 weeks)
- Change in quality-of-of life measures associated with hot flashes.(Weeks 4 and Weeks 12)
Investigators
Deborah Grady
Professor of Medicine
University of California, San Francisco