Status:
COMPLETED
Acupuncture for Hot Flushes in Menopause
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
The Research Council of Norway
University of Tromso
Conditions:
Menopause
Hot Flashes
Eligibility:
FEMALE
40-80 years
Phase:
NA
Brief Summary
In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. T...
Detailed Description
The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among ...
Eligibility Criteria
Inclusion
- Postmenopausal women (at least one year past the last menstrual period) who are willing to receive acupuncture and who during two weeks of self-completed diaries10 document a mean value of 7 flushes/24 hours or more (or 50 flushes or more over a period of seven consecutive days), will be randomized after a baseline evaluation.
- Current users prescribed medications that influence hot flush rate (e. g. HRT, SSRI's) can be included after a washout period. The washout-periods are eight weeks for SSRI's and systemic (including transdermal) HRT and four weeks for local estradiol preparations
Exclusion
- Surgical menopause
- History of cancer within the past five years
- Use of anticoagulant drugs
- Heart valve disease
- Poorly controlled hypertension
- Hypothyroidism
- Hyperthyroidism or diabetes mellitus
- Organ transplant
- Mental disease
- Overt drug or alcohol dependency
- Inability to complete study forms
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00284492
Start Date
February 1 2006
End Date
May 1 2008
Last Update
May 14 2012
Active Locations (1)
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1
Clinical Research Center, University Hospital of North Norway
Tromsø, Norway, No-9038