CLINICAL TRIALS PROFILE FOR LUPRON DEPOT-PED KIT

505(b)(2) Clinical Trials for Lupron Depot-ped Kit

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00626431 ↗	A Study of Leuprolide to Treat Prostate Cancer	Completed	Abbott	Phase 3	2008-02-01	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.

All Clinical Trials for Lupron Depot-ped Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001181 ↗	Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1982-10-01	The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods, usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some children's bodies produce these hormones before the normal age and start puberty too early. This condition is known as precocious puberty. The hormones responsible for the onset of puberty come from the pituitary gland and the ovaries. The hormones from the pituitary gland act on the ovaries to produce different hormones that cause the breasts to grow, pubic hair to develop, and menstruation. Many children with precocious puberty can be treated with a medication known as lutenizing hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a laboratory and is designed to act like the natural hormone LHRH, which is made in the pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is releasing and thereby decrease the amount of hormones released by the ovaries. However, some girls already have low levels of pituitary hormones and yet their ovaries still produce hormones. Researchers do not believe that LHRH analog therapy will work for these children. Testolactone is a drug that acts directly on the ovary. It works by preventing the last step of estrogen production in the ovary. The goal of this treatment is to stop estrogen production and delay the onset of puberty until the normal age. Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six months. If the initial treatment is successful and patients do not experience very bad side effects, they will continue to receive the medication until puberty is desired. Throughout the therapy patients will receive frequent monitoring of their general state of health, hormone levels, and medication levels.
NCT00001259 ↗	A Treatment Study for Premenstrual Syndrome (PMS)	Completed	National Institute of Mental Health (NIMH)	Phase 1	1992-08-11	This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001322 ↗	The Effects of Reproductive Hormones on Mood and Behavior	Completed	National Institute of Mental Health (NIMH)	N/A	1994-06-09	This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

Clinical Trial Conditions for Lupron Depot-ped Kit

Condition Name

Condition Name for Lupron Depot-ped Kit
Intervention	Trials
Prostate Cancer	44
Prostate Adenocarcinoma	11
Infertility	7

Condition MeSH

Condition MeSH for Lupron Depot-ped Kit
Intervention	Trials
Prostatic Neoplasms	71
Adenocarcinoma	19
Infertility	7

Clinical Trial Locations for Lupron Depot-ped Kit

Trials by Country

Trials by Country for Lupron Depot-ped Kit
Location	Trials
United States	631
Canada	39
United Kingdom	14
Germany	9
Brazil	7

Trials by US State

Trials by US State for Lupron Depot-ped Kit
Location	Trials
California	34
Texas	31
Maryland	29
New York	27
Colorado	24

Clinical Trial Progress for Lupron Depot-ped Kit

Clinical Trial Phase

Clinical Trial Phase for Lupron Depot-ped Kit
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	25
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Lupron Depot-ped Kit
Clinical Trial Phase	Trials
Completed	62
Recruiting	26
Terminated	15

Clinical Trial Sponsors for Lupron Depot-ped Kit

Sponsor Name

Sponsor Name for Lupron Depot-ped Kit
Sponsor	Trials
National Cancer Institute (NCI)	27
M.D. Anderson Cancer Center	11
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	9

Sponsor Type

Sponsor Type for Lupron Depot-ped Kit
Sponsor	Trials
Other	148
Industry	61
NIH	52

LUPRON DEPOT-PED Kit: Clinical Trials, Market Analysis, and Projections

Introduction

LUPRON DEPOT-PED Kit, containing the active ingredient leuprolide acetate, is a gonadotropin-releasing hormone (GnRH) agonist used primarily to treat central precocious puberty (CPP) in pediatric patients. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Study Designs and Objectives

Clinical trials for LUPRON DEPOT-PED Kit have been conducted in various formats to assess its efficacy and safety in treating CPP.

• 1-Month Administration: A prospective, multicenter, longitudinal study from 1991 to 2009 evaluated the efficacy and long-term safety of LUPRON DEPOT-PED 1-month administration. The study included two key phases: an open-label treatment period and a long-term post-treatment follow-up period. Primary endpoints included the suppression of clinical sexual characteristics, while secondary endpoints involved gonadotropin and sex hormone concentrations, growth rate, and safety[1].

• 3-Month Administration: A randomized, open-label clinical trial assessed the safety and efficacy of LUPRON DEPOT-PED 11.25 mg and 30 mg for 3-month administration in 84 pediatric patients. The primary endpoint was the suppression of peak stimulated luteinizing hormone (LH) to <4.0 mIU/mL[1].

• 6-Month Administration: An open-label, multicenter clinical study evaluated LUPRON DEPOT-PED 45 mg for 6-month administration in 45 pediatric patients. The study monitored LH suppression, pubertal symptoms, sex steroid levels, and bone age[4].

Key Findings

• Efficacy: LUPRON DEPOT-PED effectively suppressed clinical sexual characteristics in both males and females. For the 1-month administration, 66.7% to 90.6% of females and 60% to 100% of males showed suppression of breast and genital development, respectively. The 3-month and 6-month administrations also demonstrated sustained LH suppression and control of pubertal symptoms[1][4].

• Growth and Bone Maturation: Long-term studies indicated that growth and bone maturation normalized in patients treated with LUPRON DEPOT-PED. The mean incremental growth rate was reduced during treatment but returned to normal post-treatment, and patients essentially reached the mean height of the normal population by adulthood[1].

• Adverse Reactions: Common adverse reactions included injection site reactions, headache, psychiatric events, abdominal pain, and nausea. These reactions were generally manageable and did not lead to significant discontinuation of treatment[4][5].

Market Analysis

Market Position and Revenue

LUPRON DEPOT-PED Kit is a significant contributor to the revenue of its manufacturer, AbbVie. The drug is part of the broader hormonal therapy market and has a strong market position due to its efficacy and long-term safety profile.

• Patent Protection: LUPRON DEPOT-PED Kit is protected by two US patents and has a substantial international patent portfolio, ensuring market exclusivity for a considerable period[2].

• Generic Competition: Although a generic version of leuprolide acetate was approved by Sandoz in 1998, the branded segment of LUPRON DEPOT-PED Kit remains dominant due to its established reputation and ongoing clinical support[2].

Market Trends

The market for GnRH agonists in treating CPP is growing due to increasing awareness and diagnosis of the condition. Advances in treatment options and the need for effective management of precocious puberty drive the demand for drugs like LUPRON DEPOT-PED Kit.

Projections

Market Growth

The market for LUPRON DEPOT-PED Kit is expected to grow as more pediatric patients are diagnosed with CPP and as the drug continues to demonstrate long-term efficacy and safety.

• Increasing Diagnosis: Early diagnosis and treatment of CPP are becoming more common, which is likely to increase the demand for LUPRON DEPOT-PED Kit[1].

• Clinical Evidence: Ongoing and future clinical trials will continue to support the drug's efficacy and safety profile, reinforcing its market position[1][4].

Competitive Landscape

While generic versions of leuprolide acetate exist, the branded LUPRON DEPOT-PED Kit is expected to maintain its market share due to its strong clinical evidence and patient preference.

• Brand Loyalty: Healthcare providers and patients often prefer branded medications with extensive clinical data, which supports the continued use of LUPRON DEPOT-PED Kit[2].

• Innovation: AbbVie's ongoing research and development efforts may lead to new formulations or administration methods, further solidifying the drug's market position[2].

Key Takeaways

• Effective Efficacy: LUPRON DEPOT-PED Kit has been shown to effectively suppress clinical sexual characteristics and manage CPP in pediatric patients.
• Long-term Safety: Clinical trials have demonstrated the long-term safety and normalization of growth and bone maturation post-treatment.
• Strong Market Position: The drug enjoys a strong market position due to its patent protection, clinical evidence, and brand loyalty.
• Growing Market: The market for GnRH agonists in treating CPP is expected to grow due to increasing diagnosis and treatment rates.

FAQs

What is LUPRON DEPOT-PED Kit used for?

LUPRON DEPOT-PED Kit is used to treat central precocious puberty (CPP) in pediatric patients by suppressing the onset of early puberty.

What are the common adverse reactions associated with LUPRON DEPOT-PED Kit?

Common adverse reactions include injection site reactions, headache, psychiatric events, abdominal pain, and nausea.

How is LUPRON DEPOT-PED Kit administered?

LUPRON DEPOT-PED Kit is administered via intramuscular injection, available in 1-month, 3-month, and 6-month formulations.

What is the impact of LUPRON DEPOT-PED Kit on growth and bone maturation?

Long-term studies have shown that growth and bone maturation normalize in patients treated with LUPRON DEPOT-PED Kit, with patients reaching the mean height of the normal population by adulthood.

Is LUPRON DEPOT-PED Kit protected by patents?

Yes, LUPRON DEPOT-PED Kit is protected by two US patents and has a substantial international patent portfolio, ensuring market exclusivity.

Sources

1. Clinical Studies | LUPRON DEPOT-PED (leuprolide acetate for pediatric patients) - LupronPedPro
2. LUPRON DEPOT-PED KIT Drug Patent Profile - DrugPatentWatch
3. LUPRON DEPOT 22.5 mg for 3–month administration - FDA
4. LUPRON DEPOT-PED for 6-month administration - FDA
5. LUPRON DEPOT-PED- leuprolide acetate kit - DailyMed

Last updated: 2025-01-01