Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate, medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 milligram (mg) in participants suffering from prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Cyproterone; Cyproterone Acetate; Flutamide; Leuprolide; Medroxyprogesterone; Medroxyprogesterone Acetate; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria: - Patient has a histologically proven prostatic adenocarcinoma.

• Patient has been on a gonadotropin releasing hormone (GnRH) agonist treatment for a duration of at least 1 year.

• Karnofsky index greater than or equal to (>=) 70 %.

• Patient who, after having been clearly informed, has given his written consent to participate in the study.

Exclusion Criteria:

• Patient included in a therapeutic trial in the 3 months preceding the inclusion visit.

• Prescription of agonist planned in the context of neo-adjuvant hormonotherapy.

• Patient has symptomatic bone metastases.

• Patient already treated with hormonotherapy for his prostate cancer or has received a hormonal treatment other than a GnRH agonist for this cancer (apart from palliative care of flare-up with anti-androgens).

• Patient is unable to understand the information regarding the study provided to him, of giving his consent or who has refused to sign the informed consent sheet.

• Patient for whom risk follow up could not be guaranteed within the conditions stipulated in the protocol or is unable to complete the self-evaluation questionnaires.

• Diabetic, or patient with severe progressive disease: kidney, liver, cardiovascular (especially high uncontrolled BP), psychiatric.

• Has a Thromboembolic history or concomitant thromboembolic disease.

• Patient had hepatocellular insufficiency or hepatic cytolysis (serum glutamic oxaloacetic transaminase / serum glutamic pyruvate transaminase [SGOT/SGPT] >3 times laboratory normal range).

• Patient had a contra-indication to one of the study drugs.

• Patient receiving corticotherapy or concomitant prescription for non-selective monoamine oxidase inhibitors (MAOI), serotonin re-uptake inhibitors, clonidine, gabapentine, veripride, tibolone or beta-alanine.

• Patient was undergoing medical treatment for a depressive phase or had been treated for this during the previous 2 years before inclusion.

• Patient with a history of congenital galactosemy, poor absorption of glucose or galactose syndrome or even a lactase deficiency.

• Patient had another cancer in the 5 previous years excluding basocellular epithelioma or in situ carcinoma.