Cyproterone

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Luboslav Stárka - One of the best experts on this subject based on the ideXlab platform.

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N Mottet - One of the best experts on this subject based on the ideXlab platform.

  • 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 Oncology, 2010
    Co-Authors: Jacques Irani, L Salomon, Philippe Bouchard, N Mottet
    Abstract:

    Summary Background Hot flushes are the most common complaints reported by men undergoing androgen suppression treatment for prostate cancer. We designed a randomised double-blind trial to compare the efficacy of three drugs, each of which has proven effective for preventing hot flushes in previous studies. Methods Men with prostate cancer with an indication for androgen suppression were enrolled in the study at 106 urology centres in France between April 14, 2004, and April 20, 2007. All patients were treated for 6 months with leuprorelin (11·25 mg). At month 6, patients who spontaneously asked for treatment, or those who presented with 14 hot flushes or more during the week before the visit, were randomly assigned to either venlafaxine 75 mg daily, medroxyprogesterone acetate 20 mg daily, or Cyproterone acetate 100 mg daily. All patients received two indistinguishable pills in the morning and one in the evening from week 1 to week 8, and one indistinguishable pill in the morning from week 9 to week 10, to comply with the double-blind design. Random assignment with a block size of three was done centrally, by fax, and each patient was given a randomisation number. The allocation sequence was stratified by centre. Assessment was done at inclusion, at randomisation, and then at 4 weeks, 8 weeks, and 12 weeks after randomisation. Participants completed a daily hot-flush diary for 1 week, and a quality of life questionnaire before each visit throughout the study. The primary outcome was the change in median daily hot-flush score between randomisation and 1 month. All patients who received at least one study treatment dose were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01011751. Findings Of the 919 men initially enrolled, 311 were randomly assigned to one of the study treatments at 6 months: 102 to venlafaxine, 101 to Cyproterone, and 108 to medroxyprogesterone. 309 patients were included in the efficacy analysis, since two were excluded for protocol deviations (one in the Cyproterone and one in the medroxyprogesterone group; both were excluded because they were already undergoing treatment with serotonin reuptake inhibitor antidepressants at randomisation). The change in median daily hot-flush score between randomisation and 1 month was −47·2% (IQR −74·3 to −2·5) in the venlafaxine group, −94·5% (−100·0 to −74·5) in the Cyproterone group, and −83·7% (−98·9 to −64·3) in the medroxyprogesterone group. The decrease from baseline was significant for all three groups (p 0·2 in all cases). Serious side-effects occurred in four, seven, and five patients in the venlafaxine, Cyproterone, and medroxyprogesterone groups, respectively, of which none, one (dyspnoea), and one (urticaria) were considered related to the drug, respectively. Interpretation After 6 months of treatment with leuprorelin, venlafaxine, Cyproterone, and medroxyprogesterone proved to be effective in reducing hot flushes. However, the hormonal treatments Cyproterone and medroxyprogesterone were significantly more effective than venlafaxine. As Cyproterone is a recognised treatment in prostate cancer, and its use could interfere with hormonal therapy, medroxyprogesterone could be considered to be the standard treatment for hot flushes in men undergoing androgen suppression for prostate cancer. Funding Takeda Laboratories, Puteaux, France.

  • randomized double blind study comparing efficacy and tolerance of venlafaxine vs medroxyprogesterone acetate vs Cyproterone for hot flushes in men under leuprorelin 11 25 mg enantone for prostate cancer
    The Journal of Urology, 2009
    Co-Authors: Jacques Irani, N Mottet, L Salomon, Rostand Oba
    Abstract:

    INTRODUCTION AND OBJECTIVE: One of the most common complaints reported by men under androgen suppression for prostate cancer is hot flushes. We initiated a randomised double blind trial to compare the efficacy of 3 drugs having shown their efficacy against placebo in previous studies. A secondary objective was to evaluate their tolerance METHODS: This is a randomized double blind trial; patients were included in the study and treated for 6 months by Leuprorelin Acetate (Enantone®11.25mg) 3-monthly subcutaneous injection. At 6 month, patients who presented 14 hot flushes or more in the week preceding the visit or those who asked spontaneously for a treatment because of high discomfort due to hot flushes, were randomly assigned to venlafaxine (VLF) or medroxyprogesterone acetate (MPR) or Cyproterone acetate (CYP). Evaluation was conducted at inclusion (M0), and then at 6, 7, 8 and 9 months. A daily hot flushes diary was completed one week prior to M6 visit before starting study treatment and throughout the study. The main outcome was the reduction in the score of hot flushes at M7 compared to M6. RESULTS: 919 men were included and 311 were randomized at M6 (102, 101 and108 in the VLF, CYP and MPR groups respectively. Mean age was 73 yrs. The 3 studied drugs reduced hot flushes frequency significantly and 57% of patients were satisfied at M9 in the randomised population. Compliance was good in the 3 arms (> 96%). Hot flushes score relative change (M6-M7) venlafaxine, Cyproterone acetate, medroxyprogesterone acetate 29, 3 %, 73,6 %, 73,5 % respectively) P< 0.0001 Comparison two-two of treatment groups: P-value adjusted by bonferoni method (M6-M7) Cyproterone acetate vs medroxyprogesterone acetate p< 0.26, Cyproterone acetate vs venlafaxine p<.0001 and medroxyprogesterone acetate vs venlafaxine p<.0001 70 patients (23.6%) reported a complete regression of hot flushes after 4 weeks. This percentage was significantly lower in the venlafaxine group (8.3%) compared to the Cyproterone acetate (38.1%) and the medroxyprogesterone acetate (24%) groups (p<.001). Number of adverse events per patients was not significatly different in the 3 groups (P=0.33) CONCLUSIONS: Cyproterone acetate, medroxyprogesterone acetate and venlafaxine are effective treatments for hot flushes in prostate cancer patients on GnRH-analogs. Venlafaxine was however less effective than Cyproterone acetate and medroxyprogesterone acetate.

Richard Hampl - One of the best experts on this subject based on the ideXlab platform.

Jacques Irani - One of the best experts on this subject based on the ideXlab platform.

  • 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 Oncology, 2010
    Co-Authors: Jacques Irani, L Salomon, Philippe Bouchard, N Mottet
    Abstract:

    Summary Background Hot flushes are the most common complaints reported by men undergoing androgen suppression treatment for prostate cancer. We designed a randomised double-blind trial to compare the efficacy of three drugs, each of which has proven effective for preventing hot flushes in previous studies. Methods Men with prostate cancer with an indication for androgen suppression were enrolled in the study at 106 urology centres in France between April 14, 2004, and April 20, 2007. All patients were treated for 6 months with leuprorelin (11·25 mg). At month 6, patients who spontaneously asked for treatment, or those who presented with 14 hot flushes or more during the week before the visit, were randomly assigned to either venlafaxine 75 mg daily, medroxyprogesterone acetate 20 mg daily, or Cyproterone acetate 100 mg daily. All patients received two indistinguishable pills in the morning and one in the evening from week 1 to week 8, and one indistinguishable pill in the morning from week 9 to week 10, to comply with the double-blind design. Random assignment with a block size of three was done centrally, by fax, and each patient was given a randomisation number. The allocation sequence was stratified by centre. Assessment was done at inclusion, at randomisation, and then at 4 weeks, 8 weeks, and 12 weeks after randomisation. Participants completed a daily hot-flush diary for 1 week, and a quality of life questionnaire before each visit throughout the study. The primary outcome was the change in median daily hot-flush score between randomisation and 1 month. All patients who received at least one study treatment dose were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01011751. Findings Of the 919 men initially enrolled, 311 were randomly assigned to one of the study treatments at 6 months: 102 to venlafaxine, 101 to Cyproterone, and 108 to medroxyprogesterone. 309 patients were included in the efficacy analysis, since two were excluded for protocol deviations (one in the Cyproterone and one in the medroxyprogesterone group; both were excluded because they were already undergoing treatment with serotonin reuptake inhibitor antidepressants at randomisation). The change in median daily hot-flush score between randomisation and 1 month was −47·2% (IQR −74·3 to −2·5) in the venlafaxine group, −94·5% (−100·0 to −74·5) in the Cyproterone group, and −83·7% (−98·9 to −64·3) in the medroxyprogesterone group. The decrease from baseline was significant for all three groups (p 0·2 in all cases). Serious side-effects occurred in four, seven, and five patients in the venlafaxine, Cyproterone, and medroxyprogesterone groups, respectively, of which none, one (dyspnoea), and one (urticaria) were considered related to the drug, respectively. Interpretation After 6 months of treatment with leuprorelin, venlafaxine, Cyproterone, and medroxyprogesterone proved to be effective in reducing hot flushes. However, the hormonal treatments Cyproterone and medroxyprogesterone were significantly more effective than venlafaxine. As Cyproterone is a recognised treatment in prostate cancer, and its use could interfere with hormonal therapy, medroxyprogesterone could be considered to be the standard treatment for hot flushes in men undergoing androgen suppression for prostate cancer. Funding Takeda Laboratories, Puteaux, France.

  • randomized double blind study comparing efficacy and tolerance of venlafaxine vs medroxyprogesterone acetate vs Cyproterone for hot flushes in men under leuprorelin 11 25 mg enantone for prostate cancer
    The Journal of Urology, 2009
    Co-Authors: Jacques Irani, N Mottet, L Salomon, Rostand Oba
    Abstract:

    INTRODUCTION AND OBJECTIVE: One of the most common complaints reported by men under androgen suppression for prostate cancer is hot flushes. We initiated a randomised double blind trial to compare the efficacy of 3 drugs having shown their efficacy against placebo in previous studies. A secondary objective was to evaluate their tolerance METHODS: This is a randomized double blind trial; patients were included in the study and treated for 6 months by Leuprorelin Acetate (Enantone®11.25mg) 3-monthly subcutaneous injection. At 6 month, patients who presented 14 hot flushes or more in the week preceding the visit or those who asked spontaneously for a treatment because of high discomfort due to hot flushes, were randomly assigned to venlafaxine (VLF) or medroxyprogesterone acetate (MPR) or Cyproterone acetate (CYP). Evaluation was conducted at inclusion (M0), and then at 6, 7, 8 and 9 months. A daily hot flushes diary was completed one week prior to M6 visit before starting study treatment and throughout the study. The main outcome was the reduction in the score of hot flushes at M7 compared to M6. RESULTS: 919 men were included and 311 were randomized at M6 (102, 101 and108 in the VLF, CYP and MPR groups respectively. Mean age was 73 yrs. The 3 studied drugs reduced hot flushes frequency significantly and 57% of patients were satisfied at M9 in the randomised population. Compliance was good in the 3 arms (> 96%). Hot flushes score relative change (M6-M7) venlafaxine, Cyproterone acetate, medroxyprogesterone acetate 29, 3 %, 73,6 %, 73,5 % respectively) P< 0.0001 Comparison two-two of treatment groups: P-value adjusted by bonferoni method (M6-M7) Cyproterone acetate vs medroxyprogesterone acetate p< 0.26, Cyproterone acetate vs venlafaxine p<.0001 and medroxyprogesterone acetate vs venlafaxine p<.0001 70 patients (23.6%) reported a complete regression of hot flushes after 4 weeks. This percentage was significantly lower in the venlafaxine group (8.3%) compared to the Cyproterone acetate (38.1%) and the medroxyprogesterone acetate (24%) groups (p<.001). Number of adverse events per patients was not significatly different in the 3 groups (P=0.33) CONCLUSIONS: Cyproterone acetate, medroxyprogesterone acetate and venlafaxine are effective treatments for hot flushes in prostate cancer patients on GnRH-analogs. Venlafaxine was however less effective than Cyproterone acetate and medroxyprogesterone acetate.

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