Study of Lupron Depot In The Treatment of Central Precocious Puberty
Information source: TAP Pharmaceutical Products Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Puberty, Precocious
Intervention: Leuprolide acetate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: TAP Pharmaceutical Products Inc. Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.675 North Field Drive Lake Forest, IL 60045
Summary
The purpose of this study is to determine if leuprolide acetate is safe and effective in
treating children with Central Precocious Puberty, and to assess long term effects of
leuprolide acetate treatment after therapy is discontinued.
Clinical Details
Official title: Study of Lupron Depot In The Treatment of Central Precocious Puberty
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The clinical sexual characteristics evaluated using Tanner staging (pubic hair and genital development in males, pubic hair and breast development in females).
Secondary outcome: Hormone laboratory test results (LH suppression).Ratio of change in bone age to the change in chronological age. Predicted mature height.
Detailed description:
This study will use hormonal and physical measurements to determine if leuprolide acetate is
safe and effective for treating children with central precocious puberty. The dose of
leuprolide acetate for depot suspension will start at 300 mcg/kg (minimum 7. 5 mg), given in
the muscle every 28 days, with incremental adjustments of 3. 75 mg (minimum 7. 5 mg and
maximum15 mg) if needed based on clinical and laboratory measurements. Approximately 10 study
sites will participate in a total of 50 or more subjects. This study includes a Prestudy
Period and once enrolled, patients will be followed at least every 12 weeks for the first
year and then, every 6 months thereafter until the drug is discontinued (until the NDA is
approved or the IND is withdrawn, or until treatment is discontinued at the discretion of the
physician or parent.) At the treatment visits, gonadotropins/sex steroid levels, safety labs,
physical exam, bone age by radiograph, height, weight, and Tanner stage will be assessed. In
addition, this protocol will capture long-term outcome data on reproductive function, final
height and incidence of ovarian cysts as these children reach adulthood. Following
discontinuation of therapy (puberty), patients will be assessed for height, weight, Tanner
staging, bone age, gonadotropin / sex steroid levels, ultrasound, menstrual history for girls
and urine sample for presence of sperm for boys at specified visits for 5 years until puberty
is reached, then annually until 21 years of age for height and reproductive potential. To
collect final information on adult height, reproductive potential and ovarian cysts, patients
will be contacted and asked to return for a final clinic visit and complete a questionnaire,
have a final height and weight measurement, and females will undergo an abdominal ultrasound
to assess ovarian cysts. Following this data collection, the study will be concluded.
Eligibility
Minimum age: N/A.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
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 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 one 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).
Locations and Contacts
Additional Information
(For the Lupron PEDs Package Insert, refer to this link:) (For FDA Safety Alerts and Recalls, refer to this link:)
Starting date: January 1991
Ending date: December 2008
Last updated: June 13, 2008
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