Clinical trial · Interventional
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
NCT00233610CI-TRIAL-00004366completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary outcomes (1)
- measure
- Sexual functioning, Quality of life.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate cancer * Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy Exclusion Criteria: * Age \> 75 yrs * No metastatic disease (M1). * No presence of gynaecomastia and/or mastalgia at screening * No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.
References
Publications (0)
Data not yet available
No reference posted for this study.