The Leuprolide EIA Kit is a competitive immunoassay for in vitro quantitative measurement of (Des-Gly10, D-Leu6, Pro-NHEt9)-LHRH (Leuprolide) in serum or plasma.
Contents of Kit
1. EIA buffer concentrate 2. 96-well immunoplate with acetate plate sealer 3. Anti serum (lyophilized powder) 4. Standard (1 ug lyophilized powder) 5. Biotinylated tracer (lyophilized powder) 6. Sreptavidin-HRP 7. TMB substrate solution 8. Stop solution 9. Standard diluent 8ml 10. Datasheet 11. Protocol
Storage
Lyophilized components and standard diluent at a constant -20°C, The remaining components should be stored in the refrigerator (2-4°C)
Performance Characteristics
AVERAGE IC50: 0.4 ng/ml
Detection Range
0-10 ng/ml
Standard Curve
Citations
Publication ()
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Background
Leuprorelin, also known as leuprolide, is a gonadotropin-releasing hormone agonist (GnRH), is a synthetic non-peptide drug, similar to natural gonadotropin-releasing hormone (GnRH or LH-RH), used in the treatment of prostate cancer, breast cancer, endometriosis, uterine leiomyoma and so on. It acts by activating GnRH receptor and then affects the downstream reaction, while continuous administration can inhibit the secretion of gonadotropin in pituitary and the production of steroids in testis and ovary. Leuprorelin has relatively high stability, half-life of about 3 hours and low molecular weight, so it is a candidate for parenteral administration of protein. At present, commercial leuprorelin is in the form of acetate.
Figure 1. Amino acid composition of the principal luteinizing hormone-releasing hormone LH-RH agonists (Source: Teutonico D, et al. 2012)
Leuprolide acetate is available in several different doses and forms of administration. Bioavailability is similar for intravenous and subcutaneous administration, with less than 5% of the dose recoverable after administration of 3.75 mg. Serum gonadotropin/testosterone decreased to castration levels in men treated with leuprorelin acetate, while serum gonadotropin levels in premenopausal women decreased to postmenopausal levels, and these effects were completely reversible after discontinuation of treatment. Leuprorelin acetate is a safe and tolerated drug, but there are still some problems that need to be concerned. The biggest problem with the use of drugs such as GnRH is the initial stimulation, with serum levels of luteinizing hormone, follicle-stimulating hormone and sex steroids rising sharply after administration, which may aggravate the disease before the hormone decreases. For example, prostate patients may cause bone pain in the first few weeks of treatment, and existing symptoms may worsen (hematuria and urinary tract obstruction); patients with endometriosis and uterine fibroids may be at risk of tumor cell growth and bleeding. Therefore, during this period, it is necessary to closely monitor the patient's condition and pay attention to the dosage to make it stable enough to desensitize pituitary gonadotropin completely and effectively.
The leuprolide high sensitivity ELISA Kit from Creative Diagnostics adopts the principle of competitive immunoassay to quantitatively measure (Des-Gly10, D-Leu6, Pro-NHEt9)-leuprolide in serum or plasma. The average IC50 is 0.4 ng/mL and the detectable range is 0-10 ng/ml.
Alternative Names
Leuprorelin High Sensitivity ELISA Kit
References
1. Teutonico D, et al. Leuprolide acetate: pharmaceutical use and delivery potentials. Expert Opin Drug Deliv. 2012 Mar;9(3):343-54.
2. Desai K, et al. Hormonal Therapy for Prostate Cancer. Endocr Rev. 2021 May 25;42(3):354-373.
3. Van Poppel H, et al. Gonadotropin-releasing hormone: an update review of the antagonists versus agonists. Int J Urol. 2012 Jul;19(7):594-601.
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References
Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial.
Background: The relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial.
Methods: In this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months.
Results: Because of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79]; P=0.53).
Conclusions: PRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.
Leuprolide Acetate and QTc Interval in Gender-Diverse Youth
Transgend Health
Authors: Waldner RC, Doulla M, Atallah J, Rathwell S, Grimbly C.
Background: Puberty suppression is a standard of care for gender-affirming therapy in gender-diverse youth. Leuprolide acetate is a gonadotropin-releasing hormone agonist (GnRHa) commonly used for pubertal suppression. There are concerns that GnRHa agents prolong the rate-corrected QT interval (QTc) when used as androgen deprivation therapy in management of prostate cancer; however, there is a paucity of literature regarding the effect of leuprolide acetate on QTc intervals in gender-diverse youth.
Aim: To determine the proportion of gender-diverse youth with QTc prolongation on leuprolide acetate therapy.
Methods: A retrospective chart review of gender-diverse youth initiated on leuprolide acetate between July 1, 2018 and December 31, 2019 was conducted at a tertiary care pediatric hospital in Alberta, Canada. Youth aged 9-18 years were included if a 12-lead electrocardiogram was completed after initiating leuprolide acetate. The proportion of adolescents with clinically significant QTc prolongation was assessed, defined as QTc >460 milliseconds (ms).
Results: Thirty-three pubertal youth were included. The cohort had a mean age of 13.7 years (standard deviation [SD] 2.1) and 69.7% identified as male (assigned female at birth). The mean post-leuprolide acetate QTc was 415 ms (SD 27, range 372-455). Twenty-two (66.7%) of youth were prescribed concomitant medications, including QTc-prolonging medications in 15.2%. None of the 33 youth on leuprolide acetate had QTc prolongation. Only 24.2% patients had a borderline QTc (QTc 440-460 ms).
Conclusion: No gender-diverse youth on leuprolide acetate demonstrated clinically significant QTc prolongation.
COA
Publication 
Figure 1. Amino acid composition of the principal luteinizing hormone-releasing hormone LH-RH agonists
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