Status:
COMPLETED
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-63 years
Brief Summary
It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the et...
Eligibility Criteria
Inclusion
- Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
- Has completed 24 months of treatment.
- Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
- Was less than or equal to 62 years of age at the time of study randomization in the primary study.
- Was at least 80% compliant with test article administration.
- Did not take any medications 6 months prior to screening in the primary study or during the first 24 months of the study that could cause a change in breast density.
- Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
- Was enrolled at a clinical site that is still participating in the primary study.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
End Date :
April 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00418236
Start Date
October 1 2006
End Date
April 1 2010
Last Update
August 19 2010
Active Locations (37)
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1
San Diego, California, United States, 92108
2
Upland, California, United States, 91786
3
Meridian, Idaho, United States, 83642
4
Brooklyn Center, Minnesota, United States, 55430