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Lupron Depot PED (Leuprolide Acetate) - Summary

 
 



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 DEPOT-PED 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 one 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.

See all Lupron Depot PED indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Lupron Depot PED (Leuprolide)

Effects of metformin and leuprolide acetate on insulin resistance and testosterone levels in nondiabetic postmenopausal women: a randomized, placebo-controlled trial. [2010]
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.

The pharmacokinetics and pharmacodynamics of a new sustained-release leuprolide acetate depot compared to market references. [2008]
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

Randomized double-blind study evaluating the efficacy on uterine fibroids shrinkage and on intra-operative blood loss of different length of leuprolide acetate depot treatment before myomectomy. [2001]
CONCLUSION: Two pre-operative GnRHa depot injections offer similar results, in

Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome. [2001]
OBJECTIVE: To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS).Tibolone used in association with GnRH-a may provide long-term medical treatment for women with PMS.

Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. [2001]
OBJECTIVE: To assess the efficacy, safety, and local tolerance of ganirelix acetate for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH)... Compared with leuprolide acetate, ganirelix therapy has a shorter duration and fewer injections but produces a similar pregnancy rate.

more studies >>

Clinical Trials Related to Lupron Depot PED (Leuprolide)

Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot � (Leuprorelin Acetate - Abbot) [Recruiting]
The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot ® (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance.

Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.

Ipilimumab + Androgen Deprivation Therapy in Prostate Cancer [Recruiting]
The goal of this clinical research study is to learn if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.

A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy [Recruiting]
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.

Abiraterone Acetate, Prednisone, and Leuprolide Acetate or Goserelin Before and During Radiation Therapy in Treating Patients With Localized or Locally Advanced Prostate Cancer [Recruiting]
This phase II trial is studying the side effects and how well giving abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer

Neoadjuvant Ipilimumab in Prostate Cancer [Recruiting]
The goal of this clinical research study is to learn how ipilimumab in combination with Leupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.

more trials >>


Page last updated: 2013-02-10

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