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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Takeda
ClinicalTrials.gov Identifier:
NCT01011751
First received: November 3, 2009
Last updated: November 10, 2009
Last verified: November 2009

November 3, 2009
November 10, 2009
April 2004
December 2007   (final data collection date for primary outcome measure)
HOT FLUSHES score in week 4 of treatment after randomisation (variation in average score compared with evaluation at randomisation visit V1, expressed as a percentage). [ Time Frame: in week 4 of treatment after randomisation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011751 on ClinicalTrials.gov Archive Site
  • Frequency of HF week 4 [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • % of patients with more than 50% decrease in HF [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • % of patients having a decrease in the level of complaint HF [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • HF frequency between week 4 and 8 [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • % of patients who wish to continue after week 10 [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life(QLQ C30) [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

This is a Phase IIIb, multicentric, national, randomised, double blind. Patients are included at visit V0 (the start of treatment with leuprorelin). At the end of the 6th month (visit 1), patients who meet the eligibility criteria will be randomised to receive one of the 3 study treatments: cyproterone acetate or medroxyprogesterone acetate or venlafaxine, for 10 weeks. Evaluation visits will occur at M0 (V0), M6 (V1) then 4, 8 and 12 weeks after the randomisation visit V1.

Primary objective:

To compare the efficacy of 3 drugs (cyproterone acetate, medroxyprogesterone acetate, venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 mg in patients suffering from prostate cancer: frequency and severity of hot flushes.

Secondary objectives:

To evaluate in each treatment group:

  • the tolerance profile of the study drugs,
  • the impact of the treatment on the quality of life of patients and their satisfaction,
  • the change in the frequency and severity of hot flushes after 4 and 8 weeks of treatment,
  • the proportion of patients who wish to continue treatment after the end of the study.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: cyproterone acetate
    Androcur® 50 mg: 100 mg/day in 2 per os administrations rations.
    Other Name: Leuprorelin 11.25 mg
  • Drug: Venlafaxine
    Effexor® LP 37.5 mg: 75 mg/day in 1 per os administration
    Other Name: Enantone 11.25 mg
  • Drug: -Medroxyprogesterone
    Gestoral® 10 mg: 20 mg/day in 2 per os administer
    Other Name: Enantone 11.25 mg
  • Active Comparator: Androcur ® 50 mg
    -cyproterone acetate (Androcur® 50 mg): 100 mg/day in 2 per os administrations
    Intervention: Drug: cyproterone acetate
  • Active Comparator: Effexor® LP 37.5 mg
    -Venlafaxine (Effexor® LP 37.5 mg): 75 mg/day in 1 per os administration
    Intervention: Drug: Venlafaxine
  • Active Comparator: Gestoral® 10 mg
    -Medroxyprogesterone (Gestoral® 10 mg): 20 mg/day in 2 per os administrations.
    Intervention: Drug: -Medroxyprogesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has a histologically proven prostatic adenocarcinoma,
  • Patient has been on a GnRH agonist treatment for a duration of at least 1 year,
  • Karnofsky index >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 an 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,
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01011751
F-LEU-100, Takeda
No
Jacques IRANI / Professor, Poitiers Hospital
Laboratoires Takeda
Not Provided
Principal Investigator: jacques irani, MD Poitiers hospital
Laboratoires Takeda
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP