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Hormone Therapy

Leuprolide Acetate for Central Precocious Puberty

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 20, 44, and 48 (prior to week 48 dose); samples for lh measurement were taken 30 and 60 minutes after the stimulation test injection.
Awards & highlights

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.

Eligible Conditions
  • Central Precocious Puberty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 20, 44, and 48 (prior to week 48 dose); samples for lh measurement were taken 30 and 60 minutes after the stimulation test injection.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 20, 44, and 48 (prior to week 48 dose); samples for lh measurement were taken 30 and 60 minutes after the stimulation test injection. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24
Secondary outcome measures
Part 1: Change From Baseline in Incremental Growth Rate
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
+6 more

Side effects data

From 2023 Phase 3 trial • 45 Patients • NCT03695237
78%
INJECTION SITE PAIN
26%
HEADACHE
19%
ABDOMINAL PAIN UPPER
15%
COUGH
11%
PYREXIA
11%
OROPHARYNGEAL PAIN
11%
PRURITUS
11%
RHINORRHOEA
7%
HYPERHIDROSIS
7%
ABDOMINAL PAIN
7%
AGGRESSION
7%
SEASONAL ALLERGY
7%
PAIN IN EXTREMITY
7%
LIGAMENT SPRAIN
7%
DIARRHOEA
7%
VOMITING
7%
CRYING
7%
MULTIPLE ALLERGIES
7%
UPPER RESPIRATORY TRACT INFECTION
7%
MOOD ALTERED
7%
MOOD SWINGS
7%
COVID-19
7%
SINUSITIS
7%
EPISTAXIS
7%
RASH
7%
NASOPHARYNGITIS
4%
VULVOVAGINAL PRURITUS
4%
EAR PAIN
4%
INJECTION SITE REACTION
4%
WEIGHT INCREASED
4%
NAUSEA
4%
CHEST PAIN
4%
INJECTION SITE WARMTH
4%
BREAST PAIN
4%
NASAL CONGESTION
4%
BACK PAIN
4%
GASTROENTERITIS
4%
PHARYNGITIS STREPTOCOCCAL
4%
ATTENTION DEFICIT HYPERACTIVITY DISORDER
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprolide Acetate - Treament Naïve
Leuprolide Acetate - Previously Treated

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leuprolide Acetate (LA)Experimental Treatment1 Intervention
Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide Acetate (LA)
2018
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,339 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,053 Total Patients Enrolled

Media Library

Leuprolide Acetate (LA) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03695237 — Phase 3
Central Precocious Puberty Research Study Groups: Leuprolide Acetate (LA)
Central Precocious Puberty Clinical Trial 2023: Leuprolide Acetate (LA) Highlights & Side Effects. Trial Name: NCT03695237 — Phase 3
Leuprolide Acetate (LA) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03695237 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Apr 2025