Clinical trial · Interventional
Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma
Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma
NCT01011751CI-TRIAL-00018715completedPhase 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 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.
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 |
|---|---|---|---|
| Adenocarcinoma, Prostate | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyproterone acetate | Drug | Cyproterone Acetate | ALIAS |
| Flutamide | Drug | Flutamide | ALIAS |
| Leuprorelin | Drug | Leuprolide | ALIAS |
| Medroxyprogesterone acetate | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Venlafaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cyproterone acetate
- description
- Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, cyproterone acetate 50 mg, tablet-in-capsule, along with cyproterone acetate placebo-matching capsule, orally, once daily in the morning and cyproterone acetate 50 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Cyproterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks.
- interventionNames
- Drug: Cyproterone acetate
- Drug: Leuprorelin
- Drug: Flutamide
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Medroxyprogesterone acetate
- description
- Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, medroxyprogesterone acetate 10 mg, tablet-in-capsule, along with medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning and medroxyprogesterone acetate 10 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDIrani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. doi: 10.1016/S1470-2045(09)70338-9. Epub 2009 Dec 4. PMID 19963436