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History of Changes for Study: NCT01276028
Acupuncture in Menopause (AIM)
Latest version (submitted August 7, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 12, 2011 None (earliest Version on record)
2 January 18, 2011 Conditions and Study Status
3 April 21, 2011 Recruitment Status, Outcome Measures, Study Status and Contacts/Locations
4 April 22, 2011 Study Status
5 April 26, 2011 Outcome Measures and Study Status
6 June 9, 2011 Contacts/Locations and Study Status
7 October 5, 2011 Study Status and Eligibility
8 February 15, 2012 Study Status
9 July 23, 2012 Study Status and Arms and Interventions
10 December 21, 2012 Study Status and Arms and Interventions
11 July 9, 2013 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
12 January 23, 2014 Study Status
13 July 29, 2014 Recruitment Status and Study Status
14 February 8, 2017 Study Design, Study Status and Study Identification
15 November 2, 2017 Sponsor/Collaborators and Study Status
16 August 7, 2018 Oversight and Study Status
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Study NCT01276028
Submitted Date:  January 12, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB00014892
Brief Title: Acupuncture in Menopause (AIM)
Official Title: Acupuncture for Vasomotor Symptoms
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2011
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: January 11, 2011
First Submitted that
Met QC Criteria:
January 12, 2011
First Posted: January 13, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 12, 2011
Last Update Posted: January 13, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Wake Forest University Health Sciences
Responsible Party:
Collaborators: National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Acupunctures Effect on Hot Flashes
Keywords: Acupuncture, Hot Flashes, Menopause, Vasomotor Symptoms
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
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 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.

No Intervention: 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 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.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Subjective Hot Flashes
[ Time Frame: Weekly ]

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.
Secondary Outcome Measures:
1. Objective Hot Flashes
[ Time Frame: 3 days ]

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.
2. Other Symptoms
[ Time Frame: weekly ]

Participants will fill out a weekly symptom checklist for the entire year of the study.
3. Quality of Life
[ Time Frame: Monthly ]

Particpants will fill out questionnaires regarding their quality of Life every month for the entire 12 months of the study.
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 60 Years
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Kristen N Prevette, BA
Telephone: 336-713-0246
Email: krprevet@wfubmc.edu
Study Officials: Nancy Avis, PhD
Principal Investigator
Wake Forest University Health Sciences
Locations: United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Contact:Principal Investigator: Nancy Avis, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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