NEWS HIGHLIGHTS
Published Studies Related to Viadur (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.
Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas. [2007.11.12]
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.
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.
Clinical Trials Related to Viadur (Leuprolide)
Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy [Active, not recruiting]
Primary Objective :
- The primary objective of the study is to compare progression-free survival (PSA
progression after systemic treatment, radiologically or histologically documented
progression after systemic treatment or death from any cause, whichever occurs first),
using a 2x2 factorial design among treatment groups as follows:
- Immediate treatment following prostatectomy versus deferred treatment at the time
of relapse
- Docetaxel q3w plus leuprolide acetate versus leuprolide acetate alone
Secondary Objectives :
- To compare the 5-year overall, cancer-specific and metastasis-free survival
(metastasis-free survival based on time to clinical evidence of metastasis evidenced by
physical exam or radiologically on bone scan or CT scan) after systemic treatment
between the groups defined as follows:
- Immediate treatment following prostatectomy versus deferred treatment
- Docetaxel q3w plus leuprolide acetate versus leuprolide acetate alone
- To compare the safety and tolerability between Docetaxel in combination with leuprolide
acetate and leuprolide acetate alone.
- To evaluate quality of life as measured by the FACT-P questionnaire.
A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer [Completed]
Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone
levels are measured at set intervals to determine if Eligard is equal or better then Lupron
or Zoladex in advanced Prostate Cancer patients.
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF [Completed]
This prospective randomized trial evaluates whether one can predict which infertile women
with endometriosis who are candidates for in vitro fertilization will benefit from prolonged
therapy with a GnRH agonist by the determination of the absence of endometrial expression of
the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which
all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for
in vitro fertilization and then undergo randomization to a three month course of a depot
preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian
stimulation or standard therapy. prio
Study of Lupron Depot In The Treatment of Central Precocious Puberty [Active, not recruiting]
The purpose of this study is to determine if leuprolide acetate is safe and effective in
treating children with Central Precocious Puberty, and to assess long term effects of
leuprolide acetate treatment after therapy is discontinued.
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.
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