CompletedNot Applicable

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

China108 participantsStarted 2017-06-24

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

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)

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)

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

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 details

NCT IDNCT02993926

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-09-30

Results submitted2019-09-30

View on ClinicalTrials.gov More Central Precocious Puberty trials