Casodex - Nolvadex Combination

Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637871

Enrollment

Unknown

Registered

2008-03-18

Start date

2002-11-30

Completion date

2005-08-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynaecomastia, Prostate Cancer

Keywords

Casodex, bicalutamide, Tamoxifen, Gynaecomastia, Prostate Cancer

Brief summary

This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.

Interventions

DRUGCasodex

150mg once daily

DRUGTamoxifen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically * Subjects in need of immediate hormonal therapy. * PSA equal or above 4 ng/ml

Exclusion criteria

* Presence of gynaecomastia and/or breast pain at screening visit * Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent. * Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia . * Previous mastectomy or radiation to chest wall

Design outcomes

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026