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Hormone Therapy

Leuprolide for Precocious Puberty

Phase 3
Recruiting
Research Sponsored by Foresee Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive)
Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 48 weeks
Awards & highlights

Study Summary

This trial will test if a medicine is safe & effective for treating early puberty in kids.

Who is the study for?
This trial is for young children with early onset puberty: girls aged 2-8 and boys aged 2-9 who have been diagnosed with central precocious puberty (CPP) within the last year. They should not have had previous treatment for CPP, be able to participate in the study, and have parental consent.Check my eligibility
What is being tested?
The trial tests Leuprolide Mesylate's safety and effectiveness in treating CPP. It involves two subcutaneous injections of the drug given six months apart to see if it can safely delay early puberty symptoms.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at injection sites, hormonal changes affecting mood or growth, and other typical risks associated with hormone therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a girl aged 2-8 or a boy aged 2-9.
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My bone age is at least 1 year different from my actual age.
Select...
My bone age is under 13 years if I am a girl, or under 14 years if I am a boy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
Secondary outcome measures
Luteinizing hormone
Effect of FP-001 42 mg on bone age progression
Effect of FP-001 42 mg on growth rate
+2 more

Side effects data

From 2019 Phase 4 trial • 107 Patients • NCT03035032
17%
Prostatic specific antigen increased
9%
Cough
8%
Back pain
8%
Hot flush
6%
Anaemia
6%
Upper respiratory tract infection
4%
Pneumonia
3%
Death
2%
Neuralgia
2%
Arthralgia
2%
Haemorrhage intracranial
1%
Muscular weakness
1%
Epistaxis
1%
Fluid overload
1%
Prostate cancer metastatic
1%
Headache
1%
Dementia
1%
Deep vein thrombosis
1%
Dyspnoea
1%
Pain in extremity
1%
Chronic obstructive pulmonary disease
1%
Musculoskeletal chest pain
1%
Hyperglycaemia
1%
Syncope
1%
Pleural effusion
1%
Dysuria
1%
Septic shock
1%
Viral upper respiratory tract infection
1%
Femur fracture
1%
Spinal compression fracture
1%
Weight decreased
1%
Cardiac failure congestive
1%
Abdominal wall haematoma
1%
Anal hypoaesthesia
1%
Incarcerated inguinal hernia
1%
Inguinal hernia
1%
Inguinal hernia, obstructive
1%
Pancreatitis
1%
Proctalgia
1%
Vomiting
1%
Multiple organ dysfunction syndrome
1%
Peripheral swelling
1%
Appendicitis
1%
Gastroenteritis
1%
Sepsis
1%
Spinal cord compression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Leuprolide Acetate 22.5 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: FP-001 42 mgExperimental Treatment1 Intervention
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).

Find a Location

Who is running the clinical trial?

Changchun GeneScience Pharmaceuticals Co., Ltd.Industry Sponsor
46 Previous Clinical Trials
15,028 Total Patients Enrolled
QPSUNKNOWN
3 Previous Clinical Trials
161 Total Patients Enrolled
Foresee Pharmaceuticals Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
658 Total Patients Enrolled

Media Library

Leuprolide Mesylate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05493709 — Phase 3
Puberty Research Study Groups: FP-001 42 mg
Puberty Clinical Trial 2023: Leuprolide Mesylate Highlights & Side Effects. Trial Name: NCT05493709 — Phase 3
Leuprolide Mesylate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05493709 — Phase 3

Frequently Asked Questions

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

Does the eligibility criteria encompass individuals aged eighty-five and above?

"Participants for this study must be aged between two and nine years of age."

Answered by AI

How many medical centers are administering this clinical trial?

"Currently, 8 different clinical trial sites are accepting participants. Locations vary from San Diego to Jacksonville and Idaho Falls. It is wise for potential patients to select the nearest site in order to reduce any travel fatigue associated with participating in this experiment."

Answered by AI

What is the full enrollment capacity for this clinical trial?

"Foresee Pharmaceuticals Co., Ltd. is sponsoring the trial, which requires 93 qualified patients to operate. It will be conducted in various places of medical care such as Rady Children's Hospital- San Diego in California and Nemours Children's Health Center located in Jacksonville, Florida."

Answered by AI

What adverse effects has FP-001 42 mg been observed to cause?

"There is existing evidence affirming FP-001 42 mg's safety, so it secured a score of 3."

Answered by AI

Are there any vacancies for participation in this experiment?

"Yes, the clinicaltrial.gov website states that this research study is actively recruiting participants since its June 2nd 2023 introduction and most recent July 18th 2023 modification. The trial necessitates 93 volunteers to be recruited from 8 sites."

Answered by AI

How can I gain eligibility for participation in this trial?

"This investigation is enrolling 93 individuals who have recently entered puberty. The eligibility requirements for this research include: Females aged 2-8, and males aged 2-9; confirmation of CPP within the past 12 months without previous GnRHa treatment; LH response to a stimulation test greater than 5mIU/mL at 60 minutes post GnRHA administration; clinical evidence of pubertal development (e.g., Tanner stage ≥2 in females or Testicular volume >4 mL in males); willingness to partake in the study; Bone age - chronological age difference must be ≥1 year with bone age <13 years for girls and"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
2023. "Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05493709.
~60 spots leftby Oct 2025
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