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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)

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases [Recruiting]
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.

Pilot Study of Lupron to Improve Immune Function After Allogeneic Bone Marrow Transplantation [Recruiting]
Background:

- One way to treat certain cancers of the blood and immune system is to give a patient

stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patient's. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications.

- Researchers are studying the use of drugs that lower hormone levels and may allow the

immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug lupron, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells.

Objectives:

- To determine whether lupron improves immune system function after bone marrow

transplantation from a donor with similarities in their immune cells (matched to each other).

- To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in

imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor.

Eligibility:

- People between 15 (or as young as 9 in those who have gone through puberty) and 40

years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, or high-risk myelodysplastic syndrome. They must also be eligible for a bone marrow transplant.

- Genetically similar donors for the patients who are eligible for a transplant.

Design:

- People taking part in the study will be screened with a physical examination, medical

history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first.

- Donors will provide bone marrow for transplant according to standard bone marrow

transplant (BMT) procedures.

- All women and half of the men will receive regular lupron doses 2 weeks before BMT to

suppress hormone function.

- All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy

before the bone marrow transplant (depending on age). Recipients will also receive other drugs to prevent transplant rejection and other complications of transplantation.

- Recipients will be monitored in the hospital for 4 weeks after transplant with blood

tests and other studies.

- Some recipients will have an imaging study with FLT during the protocol. These imaging

studies will take place before the transplant, on days 5 and 28 after transplant, and at a later time to be determined by the study researchers.

- Following discharge, participants will be monitored closely for up to 6 months, with

regular but less frequent followup visits for at least 5 years. Study-related medications, including vaccinations for the new immune system, will be provided by the National Institutes of Health during the hospital stay and after discharge.

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.

Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation [Recruiting]
The purpose of this study is to help determine if palifermin and/or leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant.

The investigators want to see if palifermin and/or leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC) [Recruiting]
There is no effective standard treatment for fibrolamellar liver cancer that cannot be removed by surgery. The investigators want to find out what effects, good and/or bad, 3 drugs called letrozole, leuprolide and everolimus will have on cancer. All of these drugs are FDA approved for the treatment of different cancers. Letrozole and leuprolide stop the body from producing estrogen, a normal hormone produced by the body. Too much estrogen may help fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in the body that can help cancer grow. The combination of letrozole and leuprolide plus everolimus may work well together.

more trials >>


Page last updated: 2013-02-10

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