NCT00284492

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 30, 2006

Last Update Submit

May 11, 2012

Conditions

MenopauseHot Flashes

Keywords

WomenAcupunctureMenopauseHot flashesHealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • Frequency of hot flushes

    12 weeks

Secondary Outcomes (1)

  • Health related quality of life (Women's Health Questionnaire)

    12 weeks

Study Arms (2)

Lifestyle advice

ACTIVE COMPARATOR
Behavioral: Self Care

Lifestyle advice and acupuncture therapy

EXPERIMENTAL
Procedure: Traditional chinese medicine type acupuncture

Interventions

Traditional chinese medicine type acupuncturePROCEDURE

10 acupuncture sessions

Lifestyle advice and acupuncture therapy
Self CareBEHAVIORAL

Lifestyle advice on diet, physical activity

Lifestyle advice

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital of North Norway

Tromsø, No-9038, Norway

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Self Care

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sameline Grimsgaard, MD, MPH, PhD

    University Hospital of North Norway. No-9038 Tromsø, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

February 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2008

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

NO(1)