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Leuprolide Acetate for Central Precocious Puberty
Study Summary
This trial is testing the safety and effectiveness of a drug to treat precocious puberty in children who have either never taken this type of drug before or have taken it before with good results.
- Central Precocious Puberty
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 45 Patients • NCT03695237Trial Design
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Who is running the clinical trial?
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- Group 1: Leuprolide Acetate (LA)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Will this research be looking at older demographics?
"Eligibility for this particular research study depends on the child being between 2-11 years old. There are 13 similar studies for children and 63 for adults over the age of 65."
Has Leuprolide Acetate (LA) received FDA approval?
"Leuprolide Acetate (LA) is considered safe by our team at Power. We gave it a score of 3 because it is a Phase 3 trial, meaning that multiple rounds of testing have supported its efficacy and safety."
Who does this study require for participation?
"45 patients that currently suffer from sexual precocity and meet the following additional criteria will be accepted into the trial: Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age)., No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate"
What are the expectations of this clinical trial's outcome?
"The primary goal of this trial, which will be measured over the course of 48 weeks, is to see the percentage of participants with suppressed luteinizing hormone (LH) levels (<4 mlU/mL). Additionally, the study hopes to observe the following secondary objectives: Part 1: The percentage of female participants with suppressed levels of estradiol to <20 pg/mL, Part 2: The percentage of participants with suppressed physical signs of puberty, and Part 2: The ratio of change from baseline in bone age vs chronological age."
Are there other examples in which Leuprolide Acetate (LA) has been tested in a clinical setting?
"Leuprolide Acetate was first studied at SUNY Downstate Medical Center in 2004 and, since then, there have been a total of 141 clinical trials completed with 70 ongoing studies. A notable number of these studies are based out of Kansas City, Missouri."
Does this study have a broad geographical reach in North America?
"To minimize the impact on participants, this study is recruiting from 30 sites that are geographically dispersed. Currently, the study is looking for patients from locations including but not limited to Kansas City, Boston, and Tacoma."
What conditions does Leuprolide Acetate (LA) commonly treat?
"Leuprolide Acetate (LA) is most commonly used to treat advanced prostate cancer; however, it has also been show to be effective in managing anemia, central precocious puberty (cpp), and other conditions clinically similar to the aforementioned."
What is the census for this research project?
"Unfortunately, this particular trial is not currently looking for new patients. However, it is worth noting that the study was originally posted on October 24th, 2018 and was last edited on September 9th, 2022. Additionally, if you are interested in other studies, there are presently 9 clinical trials actively recruiting patients with sexual precocity and 70 studies for Leuprolide Acetate (LA) actively searching for participants."
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