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.
Clinical Trials Related to Lupron Depot PED (Leuprolide)
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty [Completed]
The purpose of this extension 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 (36 months).
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.
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty [Completed]
The purpose of this study is to determine if 11. 25 and 30 mg formulations of leuprolide are
effective in treating children with Central Precocious Puberty (CPP).
Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Active, not 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.
A Study of Leuprolide to Treat Prostate Cancer [Completed]
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month
depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A
formulation will be deemed successful if the percentage of subjects with suppression of
testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of
the 2-sided 90% confidence interval), a protocol-specified criterion.
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