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Acupuncture in Menopause (AIM)

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention Phase
Vasomotor Symptoms
Procedure: Acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Vasomotor Symptoms

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: April 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Waitlist
This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
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.


  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276028

Locations
United States, North Carolina
Chapel Hill Doctors
Chapel Hill, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Nancy Avis, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Nancy Avis, Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT01276028     History of Changes
Other Study ID Numbers: IRB00014892
Study First Received: January 11, 2011
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Acupuncture
Hot Flashes
Menopause
Vasomotor Symptoms

ClinicalTrials.gov processed this record on November 27, 2014