DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Lupron (Leuprolide Acetate) - 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 INJECTION (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer.


LUPRON INJECTION 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 1 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 indications & dosage >>


Media Articles Related to Lupron (Leuprolide)

Promising drug combination for advanced prostate cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.11.26]
A new drug combination may be effective in treating men with metastatic prostate cancer.

Long-term T Does Not Up Risk for High-grade Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2015.11.25]
The use of testosterone replacement therapy for up to 5 years is not associated with a subsequent increased risk of being diagnosed with high-grade prostate cancer.
Medscape Medical News

Football strengthens the bones of men with prostate cancer
Source: Bones / Orthopedics News From Medical News Today [2015.11.24]
Men with prostate cancer run the risk of brittle bones as a side-effect of their treatment.

New Model for Prostate Cancer Screening Reduces Biopsies
Source: Medscape Hematology-Oncology Headlines [2015.11.23]
A new testing algorithm has been validated as a way to reduce the number of unnecessary biopsies among men screened for prostate cancer without compromising detection of high-risk disease.
Medscape Medical News

Yoga may benefit men with prostate cancer, study finds
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2015.11.21]
Men receiving radiation therapy for prostate cancer may find twice-weekly yoga sessions can help maintain life quality and alleviate some side effects, new research suggests.

more news >>

Published Studies Related to Lupron (Leuprolide)

A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. [2011.09]
PURPOSE: We investigated the efficacy and safety of degarelix treatment and the effects of switching from leuprolide to degarelix in an ongoing extension study with a median 27.5-month followup of a pivotal 1-year prostate cancer trial... CONCLUSIONS: Data support the statistically significant prostate specific antigen progression-free survival benefit for degarelix over leuprolide seen during year 1 and the use of degarelix as first line androgen deprivation therapy as an alternative to a gonadotropin-releasing hormone agonist. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders. [2011.06.30]
We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle.

Hot flushes in prostatic cancer patients during androgen-deprivation therapy with monthly dose of degarelix or leuprolide. [2011.06]
The aim of the study was to compare the onset, incidence and frequency/intensity of hot flushes during androgen-deprivation therapy with a gonadotropin-releasing hormone antagonist (GnRH) blocker versus an agonist using data from a randomized Phase 3 clinical trial...

Randomized trial of leuprolide versus continuous oral contraceptives in the treatment of endometriosis-associated pelvic pain. [2011.04]
OBJECTIVE: To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain...

Effects of metformin and leuprolide acetate on insulin resistance and testosterone levels in nondiabetic postmenopausal women: a randomized, placebo-controlled trial. [2010.11]
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.

more studies >>

Clinical Trials Related to Lupron (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]

- 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.


- 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.

more trials >>

Reports of Suspected Lupron (Leuprolide) Side Effects

Headache (21)Fatigue (14)Hot Flush (12)Pain (9)Night Sweats (8)Abortion Spontaneous (8)Back Pain (8)Dyspnoea (8)Arthralgia (8)Bone Pain (7)more >>


Based on a total of 2 ratings/reviews, Lupron has an overall score of 5. The effectiveness score is 8 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.

Lupron review by 54 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   uterine fibroids/heavy bleeding
Dosage & duration:   one injection once a month (dosage frequency: once a month) for the period of 6 months
Other conditions:   anemia
Other drugs taken:   iron
Reported Results
Benefits:   The drug stopped my menstrual periods and put me into artificial menopause. The hope was that it would trigger my body to go into menpause and stop the heavy bleeding associated with my fibroids. Unfortunately, my period came back approximately 2 months after the last injection
Side effects:   Hot flashes, night sweats and vaginal dryness.
Comments:   I was injected once a month subcutaneously in my abdomen just below the belly button.


Lupron review by 40 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Endometriosis
Dosage & duration:   1 syringe (dosage frequency: once a month) for the period of 3 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   The Lupron suppressed the growth of the Endometriosis on my urethas.
Side effects:   I experienced memory loss.
Comments:   Received one shot during each visit once a month. Then after the third shot started having severe memory loss. Could not remember where I was driving to while in my car, could not remember where I lived etc.

See all Lupron reviews / ratings >>

Page last updated: 2015-11-26

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015