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Completed OBSERVATIONAL NCT02993926

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

The drug being evaluated in this study is called Enantone (leuprorelin). Enantone is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP. The study will enroll approximately 300 participants. All participants who have received leuprorelin 30 mcg/kg to \<90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed. This multi-center trial will be conducted in China. Data will be collected over period of 20 months.

Interventions

Name: Enantone

Type: DRUG

Description: Enantone suspension for injection

Name: GnRH agonist

Type: DRUG

Description: A non-Enantone GnRH agonist

Primary Outcomes

Measure: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase

TimeFrame: During treatment with and up to 30 days post last dose of Enantone (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months)

Description: A TEAE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Measure: Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase

TimeFrame: Mean duration of follow-up=8.75 months (range: 1.9-29.5 months) for No longer treated for CPP group; 10.80 months (range: 2.8-20.5 months) for Treated with Non-Enantone GnRHa group after treatment with Enantone (while on another GnRHa)

Measure: Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase

TimeFrame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months

Description: Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants were evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages. Participants were classified as having progression if either breast/genitals or pubic hair progression were present. Otherwise participant is classified as regression or no progression.

Measure: Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase

TimeFrame: No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 21 (586- 675 days) post last dose of Enantone

Trial Information

NCT ID

NCT02993926

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Takeda

Last Updated

December 15, 2025