N/A N=108

A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants

Central Precocious Puberty

Bottom Line

View on ClinicalTrials.gov: NCT02993926 ↗

Enrolled (actual)

108

Serious AEs

1.1%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase — 4; 71; 0; 2 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Enantone (Drug); GnRH agonist (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Takeda
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase	4; 71; 0; 2	—
PRIMARY Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase	0; 10; 9; 0; 0; 0	—
PRIMARY Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase	0; 79.7	—
PRIMARY Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase	—	—
SECONDARY Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase	100; 98.1; 100; 100	—
SECONDARY Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase	—	—
SECONDARY Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase	100; 74.8	—
SECONDARY Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase	0; 0	—
SECONDARY Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase	75.0; 90.2	—
SECONDARY Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase	100; 100	—

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.

Eligibility Criteria

Inclusion Criteria

Has diagnosis of idiopathic CPP.
Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to [>=] 90 mcg/kg up to 180 mcg/kg) or low dose (< 90 mcg/kg down to 30 mcg/kg).
Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.

Exclusion Criteria

Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
CPP participants with identified etiology, such as brain tumor or cranial irradiation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02993926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.