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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: cyproterone acetate
Drug: Venlafaxine
Drug: -Medroxyprogesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Laboratoires Takeda:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 311
Study Start Date: April 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Androcur ® 50 mg
-cyproterone acetate (Androcur® 50 mg): 100 mg/day in 2 per os administrations
Drug: cyproterone acetate
Androcur® 50 mg: 100 mg/day in 2 per os administrations rations.
Other Name: Leuprorelin 11.25 mg
Active Comparator: Effexor® LP 37.5 mg
-Venlafaxine (Effexor® LP 37.5 mg): 75 mg/day in 1 per os administration
Drug: Venlafaxine
Effexor® LP 37.5 mg: 75 mg/day in 1 per os administration
Other Name: Enantone 11.25 mg
Active Comparator: Gestoral® 10 mg
-Medroxyprogesterone (Gestoral® 10 mg): 20 mg/day in 2 per os administrations.
Drug: -Medroxyprogesterone
Gestoral® 10 mg: 20 mg/day in 2 per os administer
Other Name: Enantone 11.25 mg

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011751

Locations
France
Professor Jacques IRANI
Poitiers, France, 86021
Sponsors and Collaborators
Laboratoires Takeda
Investigators
Principal Investigator: jacques irani, MD Poitiers hospital
  More Information

No publications provided

Responsible Party: Jacques IRANI / Professor, Poitiers Hospital
ClinicalTrials.gov Identifier: NCT01011751     History of Changes
Other Study ID Numbers: F-LEU-100, Takeda
Study First Received: November 3, 2009
Last Updated: November 10, 2009
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Takeda:
hot flushes
leuprorelin 11.25 mg
Cyproterone acetate
Medroxyprogesterone acetate
Venlafaxine
Efficacy
Tolerance

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Hot Flashes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Cyproterone
Cyproterone Acetate
Diane
Medroxyprogesterone Acetate
Leuprolide
Medroxyprogesterone
Venlafaxine
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 26, 2014