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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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12 December 2020 |
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Main ID: |
NCT03316482 |
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Date of registration:
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12/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty
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Scientific title:
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A Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty |
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Date of first enrolment:
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June 11, 2015 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03316482 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jin Soon Hwang, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ajoun university hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Female children aged '= 4 years ~ < 9 years (8 years plus 364 days)
2. Those who fall under Tanner stage 2 at least (on condition that they started to have
breast budding under the age of 8)
3. Female children who showed pubertal LH response to GnRH stimulation test (peak =
7mIU/mL)
4. Those whose bone age increased by one year or more compared to their chronological age
5. Subjects and their guardians who gave written consent to participate in this study
Exclusion Criteria:
1. Those whose bone age is 11 years and 6 months or older
2. Those secreting gonadal or adrenal cortex sex hormones in a non-LH-dependent manner
3. Those who have anaphylaxis to the IP or synthetic LHRH, or LHRH derivative
4. Those who have received GnRH analog treatment
5. Those who require treatment likely to influence the hypothalamic-pituitary-gonadal
axis during the study period
6. Those receiving growth hormone
7. Those who are suspected of or diagnosed with malignant tumor
8. Patients with severe renal failure or hepatic failure, whose participation in this
study is impossible in the investigator's opinion
9. Those who have been administered one of the following drugs within 2 weeks before they
started to participate in this study, or who are expected to be administered during
the study period
- Estrogens
- Antiestrogens
- Progesterones
- Steroids
- Oriental medicines
10. Those who have participated in another clinical study within 90 days from the date
when the IP was administered
11. Those who are found to be ineligible for this study in the investigator's opinion
Age minimum:
4 Years
Age maximum:
9 Years
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: Leuplin DPS 11.25mg
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Primary Outcome(s)
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Percentage(%) of subjects with inhibition of LH response (peak <3mIU/mL)
[Time Frame: at 24 weeks]
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Secondary Outcome(s)
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LH peak/FSH ratio maintained to be <1 upon
[Time Frame: at 12, 24, and 48 weeks]
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Secondary ID(s)
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LEUPLIN3M
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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