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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 March 2022 |
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Main ID: |
NCT02993926 |
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Date of registration:
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13/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
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Scientific title:
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An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty |
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Date of first enrolment:
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June 24, 2017 |
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Target sample size:
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108 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02993926 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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China
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Contacts
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Name:
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Medical Director Clinical Science |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Has diagnosis of idiopathic CPP.
2. 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).
3. Has initiated and completed treatment during the index period from September 1st 1998
to September 30th 2018.
4. 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:
1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than
CPP.
2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone
therapy.
3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Intervention(s)
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Drug: Enantone
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Drug: GnRH agonist
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Primary Outcome(s)
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Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase
[Time Frame: 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]
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Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase
[Time Frame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months]
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Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase
[Time Frame: 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)]
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Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase
[Time Frame: 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)]
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Secondary Outcome(s)
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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
[Time Frame: 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]
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Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase
[Time Frame: No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 18 (496-585 days) post last dose of Enantone]
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Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase
[Time Frame: 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]
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Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase
[Time Frame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months]
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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
[Time Frame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months]
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Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase
[Time Frame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months]
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Secondary ID(s)
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Leuprorelin-5001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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