ELIGARD SUMMARY
ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone.
ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.
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NEWS HIGHLIGHTS
Published Studies Related to Eligard (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 Eligard (Leuprolide)
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer [Active, not recruiting]
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22. 5mg in the
treatment of subjects with prostate cancer.
Evaluate Recovery of Testosterone for Patients Using Eligard [Completed]
The purpose of this study is to determine if testosterone will recover to 90% by year 1
after using Eligard.
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.
Reports of Suspected Eligard (Leuprolide) Side Effects
Prostatic Specific Antigen Increased (6),
Pulmonary Embolism (5),
Pain (4),
Fatigue (4),
Asthenia (4),
Haemorrhage (3),
Disease Progression (3),
Diabetes Mellitus (2),
Infection (2),
Hot Flush (2), more >>
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