A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Leuprolide

Criteria

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.