MenopauseACUFLASHNCT00284492
Acupuncture for Hot Flushes in Menopause
A study testing Traditional chinese medicine type acupuncture and Self Care in people with Menopause and Hot Flashes, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Traditional chinese medicine type acupuncture and Self Care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Surgical menopause
- History of cancer within the past five years
- Use of anticoagulant drugs
- Heart valve disease
- Poorly controlled hypertension
- Hypothyroidism
Show all 11Show fewer
- Hyperthyroidism or diabetes mellitus
- Organ transplant
- Mental disease
- Overt drug or alcohol dependency
- Inability to complete study forms
Trial locations and contacts
1 site in 1 country.
Norway1 site
Clinical Research Center, University Hospital of North Norway
Tromsø, No-9038
About this study
Official title: Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
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. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.
Read the 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 women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.
The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).
- Conditions
- Menopause, Hot Flashes
- Being tested
- Traditional chinese medicine type acupuncture, Self Care
- Keywords
- Women, Acupuncture, Menopause, Hot flashes, Health related quality of life
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional chinese medicine type acupunctureProcedure or surgery
10 acupuncture sessions
Self CareBehavioural
Lifestyle advice on diet, physical activity
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle advice | Active comparator | Not described Receives: Behavioral: Self Care |
| Lifestyle advice and acupuncture therapy | Experimental | Not described Receives: Procedure: Traditional chinese medicine type acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hot flushes
Measured: 12 weeks
Secondary outcomes (1)
Health related quality of life (Women's Health Questionnaire)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Tromso
- Responsible party
- Sponsor
- Investigators
- Sameline Grimsgaard, MD, MPH, PhD, Principal investigator, University Hospital of North Norway. No-9038 Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284492
- Sponsor's protocol ID
- P REK NORD 102/2005
- Acronym
- ACUFLASH
- Status last verified
- May 2012
- First submitted
- 30 Jan 2006
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00284492
- Acronym / sponsor ID
- ACUFLASH / P REK NORD 102/2005
- Conditions
- Menopause, Hot Flashes
- Keywords
- Women, Acupuncture, Menopause, Hot flashes, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Tromso
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.
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 women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.
The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle advice | Active comparator | Behavioral: Self Care |
| Lifestyle advice and acupuncture therapy | Experimental | Procedure: Traditional chinese medicine type acupuncture |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- Surgical menopause
- History of cancer within the past five years
- Use of anticoagulant drugs
- Heart valve disease
- Poorly controlled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional chinese medicine type acupuncture10 acupuncture sessions | Procedure or surgery | Lifestyle advice and acupuncture therapy |
| Self CareLifestyle advice on diet, physical activity | Behavioural | Lifestyle advice |
Primary outcome
Frequency of hot flushes
Time frame: 12 weeks
1 secondary outcome
Health related quality of life (Women's Health Questionnaire)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameline Grimsgaard, MD, MPH, PhD principal investigator
University Hospital of North Norway. No-9038 Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional chinese medicine type acupuncture and Self Care in people with Menopause and Hot Flashes, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hot flushes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.