ACTIVE_NOT_RECRUITING

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.

Official Title

An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)

Quick Facts

Study Start:2023-06-02

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05493709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 9 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive). 2. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP. 3. Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation \> 5 mIU/mL. 4. Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males. 5. Willing and able to participate in the study. 6. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year. 7. Bone age \< 13 years for girls and \< 14 years for boys. 8. Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the custodial parent(s) or by the legal guardian(s) (if required). 9. Signed Assent by patients as per IRB/IEC requirements.	1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. This includes true CPP triggered by other conditions, such as congenital adrenal hyperplasia. 2. Prior or current GnRH treatment for CPP. 3. Non-progressing isolated premature thelarche. 4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Patients with hamartomas or adenomas not requiring surgery are eligible. 5. Any other condition, chronic illness or treatment that, in the opinion of the Investigator, may interfere with growth or other study endpoints (e.g., chronic steroid use \[except mild topical steroids\], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor). 6. Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1). 7. Major medical or psychiatric illness that could interfere with study visits. 8. Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age). 9. Positive urine pregnancy test. 10. Known hypersensitivity to GnRH or related compounds. 11. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study. 12. Any other condition(s) which could significantly interfere with Protocol compliance. 13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0). 14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions. 15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per Investigator opinion, have been associated with seizures or convulsions.

Inclusion Criteria

Exclusion Criteria

1. Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
2. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
3. Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation \> 5 mIU/mL.
4. Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
5. Willing and able to participate in the study.
6. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
7. Bone age \< 13 years for girls and \< 14 years for boys.
8. Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the custodial parent(s) or by the legal guardian(s) (if required).
9. Signed Assent by patients as per IRB/IEC requirements.

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. This includes true CPP triggered by other conditions, such as congenital adrenal hyperplasia.
2. Prior or current GnRH treatment for CPP.
3. Non-progressing isolated premature thelarche.
4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Patients with hamartomas or adenomas not requiring surgery are eligible.
5. Any other condition, chronic illness or treatment that, in the opinion of the Investigator, may interfere with growth or other study endpoints (e.g., chronic steroid use \[except mild topical steroids\], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
6. Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
7. Major medical or psychiatric illness that could interfere with study visits.
8. Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
9. Positive urine pregnancy test.
10. Known hypersensitivity to GnRH or related compounds.
11. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study.
12. Any other condition(s) which could significantly interfere with Protocol compliance.
13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0).
14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions.
15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per Investigator opinion, have been associated with seizures or convulsions.

Contacts and Locations

Principal Investigator

Susan Whitaker

STUDY_DIRECTOR

Foresee Pharma

Study Locations (Sites)

Arizona University

Tucson, Arizona, 85719

United States

Rady Children's Hospital- San Diego

San Diego, California, 92123

United States

Nemours Children's Health Center

Jacksonville, Florida, 32207

United States

Johns Hopkins - All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404

United States

Indiana University

Indianapolis, Indiana, 46202

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Cook Children's

Fort Worth, Texas, 76104

United States

Virginia University

Charlottesville, Virginia, 22908

United States

Multicare Health System

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: Foresee Pharmaceuticals Co., Ltd.

Susan Whitaker, STUDY_DIRECTOR, Foresee Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-02

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-06-02

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Puberty; Precocious, Central