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Trial Outcomes & Findings for Women's Mammography Study To Improve Comfort During Mammography (NCT NCT01716052)

NCT ID: NCT01716052

Last Updated: 2015-12-30

Results Overview

The primary outcome measure will be the response to questions on a questionnaire.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

3 years

Results posted on

2015-12-30

Participant Flow

When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.

Participant milestones

Participant milestones
Measure
Ibuprofen
Pfizer 200 mg caplets (Advil) Ibuprofen
Placebo
Lactulose placebo: Lactulose
Overall Study
STARTED
1
1
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Ibuprofen
Pfizer 200 mg caplets (Advil) Ibuprofen
Placebo
Lactulose placebo: Lactulose
Overall Study
Withdrawal of funding
1
1

Baseline Characteristics

Women's Mammography Study To Improve Comfort During Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ibuprofen
n=1 Participants
Pfizer 200 mg caplets (Advil) Ibuprofen
Placebo
n=1 Participants
Lactulose placebo: Lactulose
Total
n=2 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants

PRIMARY outcome

Timeframe: 3 years

Population: No data was collected or analyzed for the outcome measure because the study was terminated.

The primary outcome measure will be the response to questions on a questionnaire.

Outcome measures

Outcome data not reported

Adverse Events

Ibuprofen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Kist

UTHSCSA @CTRC

Phone: 210-450-5600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place