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Lupron (Leuprolide Acetate) - Summary

 



LUPRON SUMMARY

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.

LUPRON INJECTION (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer.

INDICATIONS AND USAGE

LUPRON INJECTION is indicated in the treatment of children with central precocious puberty. Children should be selected using the following criteria:

  1. Clinical diagnosis of CPP (idiopathic or neurogenic) with onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males.
  2. Clinical diagnosis should be confirmed prior to initiation of therapy:
      Confirmation of diagnosis by a pubertal response to a GnRH stimulation test. The sensitivity and methodology of this assay must be understood.
    • Bone age advanced 1 year beyond the chronological age.
  3. Baseline evaluation should also include:
      Height and weight measurements.
    • Sex steroid levels.
    • Adrenal steroid level to exclude congenital adrenal hyperplasia.
    • Beta human chorionic gonadotropin level to rule out a chorionic gonadotropin secreting tumor.
    • Pelvic/adrenal/testicular ultrasound to rule out a steroid secreting tumor.
    • Computerized tomography of the head to rule out intracranial tumor.

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NEWS HIGHLIGHTS

Media Articles Related to Lupron (Leuprolide)

Tulane Cancer Center To Begin Novel Clinical Trial For Late-Stage Prostate Cancer Drug
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.18]
International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer Center is the first oncologist in the United States to offer patients an experimental new treatment for late-stage prostate cancer through a multi-center clinical trial that is currently recruiting patients at 100 sites across 20 countries worldwide.

Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies Of Apoptone (HE3235) At AACR Molecular Targets Conference
Source: Conferences News From Medical News Today [2009.11.17]
Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC).

Anxiety And Distress During Active Surveillance For Early Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - The present study found that the majority of men with early prostate cancer (PC) included in a protocol-based program for active surveillance (AS) show favorable anxiety and distress scores when compared to reference values and to groups of patients with PC who underwent other treatments.

Percentage Of Positive Biopsy Cores At The Onset Of Hormone Therapy For Prostate Cancer: Prognostic Significance
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Accurate prediction of outcome after hormonal treatment for localized prostate cancer is important for patient counselling, follow-up, treatment planning and research protocol design. Few prognostic tools incorporating pre-therapeutic parameters are available to increase disease relapse predictions and survival.

Degarelix: A New Approach For The Treatment Of Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Gonadotrophin-releasing hormone (GnRH) agonists are currently the 'standard of care' for androgen deprivation therapy (ADT) in prostate cancer. Improvements in ADT would have a great value for many patients. The agonists are associated with an initial testosterone surge, which delays castration and may stimulate tumor growth and induce 'clinical flare' in patients with symptomatic advanced disease.

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Published Studies Related to Lupron (Leuprolide)

Leuprolide acetate reduces both in vivo and in vitro ovarian steroidogenesis in infertile women undergoing assisted reproduction. [2008.12.22]
Despite the probable inhibitory effects of GnRH analogues on ovarian steroidogenesis in vitro, their association with assisted reproduction protocols shows favorable results. This suggests that there are important differences in the behaviors of these drugs when administered in vivo versus in vitro...

The pharmacokinetics and pharmacodynamics of a new sustained-release leuprolide acetate depot compared to market references. [2008.08]
OBJECTIVE: The aim of this study was to compare the efficacy of Lutrate 3.75 and 7.5 mg depot to marketed references Lucrin 3.75 mg and Procrin 7.5 mg depot... CONCLUSION: Sustained release of leuprolide from this new depot formulation suppressed testosterone levels at least as effectively and for a longer period of time than the reference products.

Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas. [2008.07]
OBJECTIVE: To investigate the effects of tibolone co-administration with GnRH agonist treatment in terms of cognition, mood, and quality of life... CONCLUSION(S): Tibolone administration reverses the deleterious effect on cognition that is caused by leuprolide acetate depot and improves mood and quality of life in patients who receive GnRH agonist for symptomatic uterine leiomyomas.

Single-dose depot leuprolide is as efficient as daily short-acting leuprolide in ICSI cycles. [2007.06]
BACKGROUND In this prospective randomized study, we aimed to compare the efficacy of a single depot (1.88 mg) reduced dose with a daily low dose (0.5 mg/day) of leuprolide for pituitary suppresion as part of controlled ovarian hyperstimulation (COH) in an ICSI program... CONCLUSIONS A single reduced depot dose (1.88 mg) of leuprolide was found to be as effective as classical long multi-dose protocol for pituitary desensitization in COH for ICSI cycles.

Impact of leuprolide acetate on luteal phase function in women undergoing controlled ovarian hyperstimulation and intrauterine insemination. [2006.02]
OBJECTIVE: To determine if the combination of leuprolide acetate (LA) and human menopausal gonadotropin (hMG) results in luteal phase dysfunction... The E2 levels on the day of hCG administration in both groups were lower in women with documented luteal phase defects.

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Clinical Trials Related to Lupron (Leuprolide)

Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients [Recruiting]
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later.

The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared.

This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.

Melanoma Vaccine With Peptides and Leuprolide [Recruiting]
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.

Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer [Recruiting]
The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood and prostate. For this study, patients are required to be suitable candidates for a radical prostatectomy (prostate surgery) which will be performed after 24 weeks of treatment.

Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty [Recruiting]
The purpose of this 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 (12 months).

Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Recruiting]
(A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor: 1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether quality of life, assessed by questionnaire, is better in patients assigned to NA than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH agonist.

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Page last updated: 2009-11-18

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