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

2014-08-27 03:18:03 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

cyproterone acetate, Venlafaxine, -Medroxyprogesterone

Location

Professor Jacques IRANI
Poitiers
France
86021

Status

Completed

Source

Laboratoires Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:03-0400

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Medical and Biotech [MESH] Definitions

An anti-androgen that, in the form of its acetate (CYPROTERONE ACETATE), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females.

An androstene derivative that inhibits STEROID 17-ALPHA-HYDROXYLASE and is used as an ANTINEOPLASTIC AGENT in the treatment of metastatic castration-resistant PROSTATE CANCER.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.

An agent with anti-androgen and progestational properties. It shows competitive binding with dihydrotestosterone at androgen receptor sites.

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