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Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW


Phase 4
18 Years
63 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW

Inclusion Criteria


1. Each subject must have participated or is currently participating in study 3068A1
301, and must satisfy all of the following criteria

2. Has completed 24 months of treatment.

3. Had a mammogram at the baseline visit and at the month 24 visit, and both are
original films that are technically acceptable for reading.

4. Was less than or equal to 62 years of age at the time of study randomization in the
primary study.

5. Was at least 80% compliant with test article administration.

6. 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.

7. Was enrolled at a site that has at least 4 subjects meeting all of the above
inclusion criteria.

8. Was enrolled at a clinical site that is still participating in the primary study.

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3068A1-400

NCT ID:

NCT00418236

Start Date:

October 2006

Completion Date:

April 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Alexandria, Minnesota  56308
Great Falls, Montana  59405
Fountain Valley, California  92708
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501
Coeur D'alene, Idaho  83814