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Women's Mammography Study To Improve Comfort During Mammography

This study has been terminated.
(Lack of funding.)
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio Identifier:
First received: October 18, 2012
Last updated: December 1, 2015
Last verified: December 2015
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

Condition Intervention
Drug: placebo
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Measure of Discomfort of Mammography [ Time Frame: 3 years ]
    The primary outcome measure will be the response to questions on a questionnaire.

Enrollment: 2
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
Drug: Ibuprofen
Placebo Comparator: Placebo
Drug: placebo

Detailed Description:
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must have signed the informed consent.
  • Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion Criteria:

  • May not have taken ibuprofen or other pain medication within the last 12 hours.
  • Must not have a contraindication for taking ibuprofen e.g:
  • No history of allergic reactions to ibuprofen or aspirin
  • No recent history with the last year of bleeding from GI tract
  • Not pregnant or suspected of being pregnant
  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 identifier: NCT01716052

United States, Texas
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Kenneth A. Kist,
Principal Investigator: Kenneth Kist, MD University of Texas
  More Information

Responsible Party: Kenneth A. Kist,, Principal Investigator, The University of Texas Health Science Center at San Antonio Identifier: NCT01716052     History of Changes
Other Study ID Numbers: CTRC 11-45
HSC20120142H ( Other Identifier: UTHSCSA IRB )
Study First Received: October 18, 2012
Results First Received: January 13, 2015
Last Updated: December 1, 2015

Keywords provided by The University of Texas Health Science Center at San Antonio:
Pain management

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017