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Leuprolide acetate in depot suspension
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production.
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production. Used for Endometriosis, Uterine fibroids (leiomyomata), Precocious puberty.
At a glance
| Generic name | Leuprolide acetate in depot suspension |
|---|---|
| Also known as | Depot Lupron |
| Sponsor | Colorado Center for Reproductive Medicine |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Leuprolide works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in profound suppression of testosterone in males and estrogen in females. The depot suspension formulation provides sustained release over weeks to months, maintaining therapeutic hormone suppression.
Approved indications
- Endometriosis
- Uterine fibroids (leiomyomas)
- Assisted reproductive technology (ART) / in vitro fertilization (IVF) support
- Precocious puberty
Common side effects
- Hot flashes
- Headache
- Mood changes / depression
- Vaginal dryness
- Injection site reactions
- Decreased libido
- Bone density loss (with prolonged use)
Key clinical trials
- The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (PHASE2)
- Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (PHASE4)
- Prevention of Obesity in Women Via Estradiol Regulation (PHASE3)
- Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (PHASE3)
- Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women (NA)
- Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF (PHASE4)
- Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |