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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00418236
Date of registration:	02/01/2007
Prospective Registration:	No
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Scientific title:	Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
Date of first enrolment:	October 2006
Target sample size:	400
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00418236
Study type:	Observational
Study design:	Time Perspective: Retrospective
Phase:

Countries of recruitment
Argentina	Brazil	Bulgaria	Canada	Chile	Croatia	Denmark	Estonia
Mexico	Netherlands	Poland	Romania	South Africa	United States

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Netherlands, trials-NL@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Croatia, WPBUMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Argentina, Scheima@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Chile, scheima@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Romania, WVPIMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Denmark, medinfonord@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Poland, WPWZMED@wyeth.com

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Brazil, xavierl@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Bulgaria, WVPIMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Canada, clintrialparticipation@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Mexico, gomezzlj@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Estonia, WVPMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For South Africa, ZAFinfo@wyeth.com

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 63 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

3068A1-400

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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