Status:
COMPLETED
Menopausal Treatment Using Relaxation Exercises (MaTURE)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Hot Flushes
Hot Flashes
Eligibility:
FEMALE
40-59 years
Phase:
NA
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 fla...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women aged 40 through 59 years at the time of screening.
- Perinenopausal or postmenopausal.
- Adequate adherence to study procedures during a 1-week run-in.
- At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.
- Capable of understanding study procedures and giving informed consent.
- Willing to refrain from using other treatments for hot flashes during the study period.
- Exclusion criteria
- Pregnant or breastfeeding in the past year.
- Current or recent use of medications known to affect hot flashes.
- Resting blood pressure less than 100/60.
- Spontaneous resting breathing rate less than 10 breaths/minute.
- Chronic medical therapy for pulmonary disease.
- Known sensitivity to adhesives.
- Cardiac pacemaker or implanted defibrillator.
- No access to a telephone.
- Plans to move out of the area or travel by airplane in ways that would interfere with the study.
- Inability to sign an informed consent, participate in interviews, or understand and complete questionnaires in English.
- Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol.
- Participation in another research study involving investigational drugs or devices.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01466998
Start Date
January 1 2012
End Date
April 1 2014
Last Update
May 6 2014
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94115