VIADUR SUMMARY
Viadur® (leuprolide acetate implant)
Viadur® (leuprolide acetate implant) is a sterile nonbiodegradable, osmotically driven miniaturized implant designed to deliver leuprolide acetate for 12 months at a controlled rate (Figure A). Viadur® incorporates DUROS® technology. The system contains 65 mg of leuprolide (free base). Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The implant is inserted subcutaneously in the inner aspect of the upper arm. After 12 months, the implant must be removed. At the time an implant is removed, another implant may be inserted to continue therapy.
Viadur® is indicated in the palliative treatment of advanced prostate cancer.
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NEWS HIGHLIGHTS
Published Studies Related to Viadur (Leuprolide)
A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. [2011.09]
PURPOSE: We investigated the efficacy and safety of degarelix treatment and the effects of switching from leuprolide to degarelix in an ongoing extension study with a median 27.5-month followup of a pivotal 1-year prostate cancer trial... CONCLUSIONS: Data support the statistically significant prostate specific antigen progression-free survival benefit for degarelix over leuprolide seen during year 1 and the use of degarelix as first line androgen deprivation therapy as an alternative to a gonadotropin-releasing hormone agonist. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders. [2011.06.30]
We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle.
Hot flushes in prostatic cancer patients during androgen-deprivation therapy with monthly dose of degarelix or leuprolide. [2011.06]
The aim of the study was to compare the onset, incidence and frequency/intensity of hot flushes during androgen-deprivation therapy with a gonadotropin-releasing hormone antagonist (GnRH) blocker versus an agonist using data from a randomized Phase 3 clinical trial...
Randomized trial of leuprolide versus continuous oral contraceptives in the treatment of endometriosis-associated pelvic pain. [2011.04]
OBJECTIVE: To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain...
Effects of metformin and leuprolide acetate on insulin resistance and testosterone levels in nondiabetic postmenopausal women: a randomized, placebo-controlled trial. [2010.11]
OBJECTIVE: To determine whether insulin sensitizers lower androgen levels and whether androgen suppression improves insulin resistance in nondiabetic postmenopausal women... They confirm that treatment of insulin resistance decreases T production in this population and demonstrate that pharmacologic lowering of T does not affect insulin resistance.
Clinical Trials Related to Viadur (Leuprolide)
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty [Completed]
The purpose of this study is to determine if 11. 25 and 30 mg formulations of leuprolide are
effective in treating children with Central Precocious Puberty (CPP).
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty [Completed]
The purpose of this extension study is to determine if leuprolide acetate (11. 25 mg and 30
mg) is safe in treating children with Central Precocious Puberty over a longer period of
time (36 months).
A Study of Leuprolide to Treat Prostate Cancer [Completed]
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month
depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A
formulation will be deemed successful if the percentage of subjects with suppression of
testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of
the 2-sided 90% confidence interval), a protocol-specified criterion.
Melanoma Vaccine With Peptides and Leuprolide [Completed]
The goal of this clinical research study is to learn if the drug leuprolide will increase
the level of immune cells in your body. Researchers will also want to know if this drug
given together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor
fighting immune cells (T cells) to fight melanoma cells.
Primary Objective:
1. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines,
gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone
(LHRH) agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or
stage IV melanoma that the metastatic lesion(s) has been surgically removed.
Secondary Objectives:
1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow
cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients.
2. To assess whether there are significant differences in overall quality of life (QOL)
between patients receiving Leuprolide to those not receiving leuprolide.
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer [Active, not recruiting]
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and
safety of CAM2032 q1m versus Eligard, in patients with prostate cancer. All patients will
receive leuprolide acetate administered subcutaneously once monthly during 3 months.
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