Clinical Trial: Casodex - Nolvadex Combination

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of

To describe the extent of gynaecomastia and breast pain by treatment group

To describe the relative change from baseline in sex hormones concentrations by treatment group

To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily

To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily

Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: March 12, 2008
Date Started: November 2002
Date Completion:
Last Updated: January 21, 2011
Last Verified: January 2011