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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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19 October 2017 |
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Main ID: |
NCT00660010 |
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Date of registration:
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15/04/2008 |
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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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Study of Lupron Depot In The Treatment of Central Precocious Puberty
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Scientific title:
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Study of Lupron Depot In The Treatment of Central Precocious Puberty |
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Date of first enrolment:
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January 1991 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00660010 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Kristof Chwalisz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores
of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II
for pubic hair or genitalia earlier than 9.0 years in boys.
- Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone
(GnRH) stimulation test (LH > 10 U/L at baseline).
- Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time
of first dosing.
- Bone age advanced at least 1 year beyond the chronological age at entry into the
study.
- The condition may be idiopathic or secondary to another lesion. If secondary, therapy
of the primary condition will have been undertaken and stabilized.
- No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for
premature secretion of gonadotropins.
Exclusion Criteria:
- Irradiation to the central nervous system.
- Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including
prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).
Age minimum:
N/A
Age maximum:
10 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Puberty, Precocious
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Intervention(s)
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Drug: Lupron (leuprolide acetate)
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Primary Outcome(s)
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Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)
[Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)
[Time Frame: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Secondary Outcome(s)
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Mean Stimulated Estradiol Concentrations in Females
[Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Mean Ratio of Bone Age to Chronological Age
[Time Frame: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations
[Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Mean Stimulated Testosterone Concentrations in Males
[Time Frame: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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