Central Precocious Puberty Clinical Trial
Official title:
An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)
Verified date | February 2024 |
Source | Takeda |
Contact | Takeda Contact |
Phone | +1-877-825-3327 |
medinfoUS[@]takeda.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 9 Years |
Eligibility | Inclusion Criteria: 1. Early appearance of secondary sexual characteristics: Girls =8 years, Boys =9years 2. Body weight =20 kg 3. According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level >5.0 IU/L with LH/FSH >0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles =4 mm in any ovary or uterine enlargement in females or testicular volume =4 mL in males); advanced bone age (BA) =1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening. Exclusion Criteria: 1. The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent. 2. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. 3. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. 4. The participant has a diagnosis of peripheral precocious puberty. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Children's Hospital, Capital Medical University | Beijing | Beijing |
China | the First A liated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
China | Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | Shanghai Children's Hospital | Shanghai | Shanghai |
China | The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University. | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Takeda |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 | The LH suppression is defined as LH peak value in GnRH stimulation =3.0 international unit per liter (IU/L). | Week 24 | |
Secondary | Percentage of Participants with Tanner Stage Regression or No Progression at Week 24 | Tanner Stage is used to measure pubertal development. Tanner Stage is based on progression through 5-stages. The progression was defined that either breast/genitals or pubic hair score had increased score compared with baseline score. Otherwise, the status was classified as regression or no progression. Baseline is defined as the assessment prior to the first dose of study drug. | Baseline and Week 24 | |
Secondary | Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) | Plasma LH and FSH peak concentrations under GnRH stimulation will be assessed. | Baseline, Week 24 and 36 | |
Secondary | Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24 | Bone age will be determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards. | Baseline and Week 24 | |
Secondary | Percentage of Participants with Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 | Baseline and Week 24 | ||
Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (Up to approximately 38 weeks) |
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