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Acupuncture in Menopause (AIM)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy Avis, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01276028
First received: January 11, 2011
Last updated: July 29, 2014
Last verified: July 2014
History of Changes

January 11, 2011
July 29, 2014
April 2011
July 2014   (final data collection date for primary outcome measure)
Subjective Hot Flashes [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months (post randomization) of the study and then 1 week per month for the remaining 6 months of the study.
Subjective Hot Flashes [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months of the study and then 1 week per month for the additional 6 months of the study. Participants are followed approximately 1 year from enrollment.
Complete list of historical versions of study NCT01276028 on ClinicalTrials.gov Archive Site
  • Objective Hot Flashes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Objective hot flashes measured by skin conductance
  • Other Symptoms [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
    Measures your quality of life over the last week
  • Objective Hot Flashes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Hot Flashes will be monitored by a Hot Flash Monitor that the participant will wear 3 days a month for the first six months of the study and then 3 days every other month for the remaining 6 months of the study. The participants are followed for approximately 1 year from enrollment.
  • Other Symptoms [ Time Frame: weekly ] [ Designated as safety issue: No ]
    Participants will fill out a weekly symptom checklist for the entire year of the study.
  • Quality of Life [ Time Frame: Monthly ] [ Designated as safety issue: No ]
    Particpants will fill out questionnaires regarding their quality of Life every month for the entire 12 months of the study.
Not Provided
Not Provided
 
Acupuncture in Menopause
Acupuncture for Vasomotor Symptoms
The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vasomotor Symptoms
Procedure: Acupuncture

For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate.

Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.
  • Experimental: Acupuncture
    This group will start acupuncture treatments within 3 weeks of consent and continue to receive up to 20 treatments over a six month period. The number of treatments will be jointly determined by the participant and the acupuncturist.
    Intervention: Procedure: Acupuncture
  • Waitlist
    This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
    Intervention: Procedure: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women experiencing on average 4 Hot Flashes a day
  • Women aged 45-60
  • Peri or Post menopausal Women (No periods for at least 3 months)

Exclusion Criteria:

  • Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks
  • Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
  • Women who have initiated antidepressants in the last 3 months
  • Women who have changed their dose of an antidepressant in the last 3 months
  • Women who have had acupuncture in the last 4 weeks
  • Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study
  • Women who describe their health as fair or poor are excluded from the study
  • Women who have a diagnosis of Hemophilia
  • Relatives and Co-Workers of the treating acupuncturists
Female
45 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01276028
IRB00014892
Yes
Not Provided
Not Provided
Nancy Avis, Wake Forest Baptist Health
Wake Forest Baptist Health
National Institutes of Health (NIH)
Principal Investigator: Nancy Avis, PhD Wake Forest School of Medicine
Wake Forest Baptist Health
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP