Lupron Depot (Leuprolide Acetate) - Summary

LUPRON DEPOT 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.

ENDOMETRIOSIS:

LUPRON DEPOT 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT monthly with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. (Refer also to norethindrone acetate prescribing information for WARNINGS, PRECAUTIONS, CONTRAINDICATIONS and ADVERSE REACTIONS associated with norethindrone acetate). Duration of initial treatment or retreatment should be limited to 6 months.

UTERINE LEIOMYOMATA (FIBROIDS):

LUPRON DEPOT 3.75 mg concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. (See Table 1.) LUPRON may be added if the response to iron alone is considered inadequate. Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to three months.

Experience with LUPRON DEPOT in females has been limited to women 18 years of age and older.

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NEWS HIGHLIGHTS

Media Articles Related to Lupron Depot (Leuprolide)

New Way Found to Diagnose Endometriosis
Source: MedicineNet Endometriosis Specialty [2009.08.21]
Title: New Way Found to Diagnose Endometriosis
Category: Health News
Created: 8/20/2009 2:10:00 PM
Last Editorial Review: 8/21/2009

MRI May Help Find Deep Endometriosis
Source: MedicineNet Endometriosis Specialty [2009.07.08]
Title: MRI May Help Find Deep Endometriosis
Category: Health News
Created: 7/8/2009 7:00:00 AM
Last Editorial Review: 7/8/2009

Endometriosis
Source: MedicineNet Breast Specialty [2009.02.19]
Title: Endometriosis
Category: Medical Dictionary
Created: 3/26/1998 2:24:00 PM
Last Editorial Review: 2/19/2009

Health Tip: Risk Factors for Endometriosis
Source: MedicineNet Endometriosis Specialty [2008.12.26]
Title: Health Tip: Risk Factors for Endometriosis
Category: Health News
Created: 12/26/2008 2:00:00 AM
Last Editorial Review: 12/26/2008

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Published Studies Related to Lupron Depot (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.

Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain. [2006.02]
OBJECTIVE: To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis... CONCLUSION(S): Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.

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Clinical Trials Related to Lupron Depot (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.

Lupron Sex Offender Therapy [Active, not recruiting]
This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was administered by Depo injection (7 mg initially, then 22. 5 mg every 3 mos) for 12 months, followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong urges and masturbatory frequency to children (polygraph), were measured every three months. Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal response as measured by penile plethysmography (penile tumescence) was significantly suppressed compared with baseline. However, sufficient response remained to detect pedophilic interest. This pedophilic interest was also detected by visual reaction times. All subjects self-reported a decrease in strong pedophilic urges and masturbation. When asked about having pedophilic urges and masturbating to thoughts of children, polygraph responses indicated subjects were not deceptive when they reported decreases. On placebo, testosterone and physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not change pedophilic interest during one year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia. Our study supports the supposition that modification of pedophilic behavior is possible. LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.

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