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Study of Lupron Depot In The Treatment of Central Precocious Puberty

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Puberty, Precocious

Intervention: Lupron (leuprolide acetate) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Kristof Chwalisz, MD, Study Director, Affiliation: Abbott

Summary

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), 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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)

Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)

Secondary outcome:

Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations

Mean Stimulated Estradiol Concentrations in Females

Mean Stimulated Testosterone Concentrations in Males

Mean Ratio of Bone Age to Chronological Age

Detailed description: This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old. At the treatment visits, efficacy assessments are Tanner staging (suppression of breast development in females and genital development in males), gonadotropins (LH and FSH), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

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 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).

Locations and Contacts

Site Reference ID/Investigator# 46673, Phoenix, Arizona 85006, United States

Site Reference ID/Investigator# 46671, San Francisco, California 94122, United States

Site Reference ID/Investigator# 14921, Stanford, California 94305, United States

Site Reference ID/Investigator# 14343, Aurora, Colorado 80045, United States

Site Reference ID/Investigator# 14341, St. Petersburg, Florida 33701, United States

Site Reference ID/Investigator# 14342, Indianapolis, Indiana 46202, United States

Site Reference ID/Investigator# 46672, Baltimore, Maryland 21201, United States

Site Reference ID/Investigator# 46668, Springfield, Massachusetts 01199, United States

Site Reference ID/Investigator# 14344, Hershey, Pennsylvania 17033, United States

Additional Information

Starting date: January 1991
Last updated: April 8, 2011

Page last updated: August 23, 2015

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