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Clinical Trials/NCT01466998
NCT01466998CompletedNot Applicable

Menopausal Treatment Using Relaxation Exercises (MaTURE)

University of California, San Francisco2 sites in 1 country123 target enrollmentStarted: January 2012Last updated:
Conditions

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Deborah Grady

Professor of Medicine

University of California, San Francisco

Study Sites (2)

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