Study of Lupron Depot In The Treatment of Central Precocious Puberty
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00660010
First received: April 15, 2008
Last updated: April 8, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Puberty, Precocious |
Drug: Lupron (leuprolide acetate) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Lupron Depot In The Treatment of Central Precocious Puberty |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
Drug Information available for:
Leuprolide acetate
U.S. FDA Resources
Further study details as provided by Abbott:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).
- 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 ] [ Designated as safety issue: No ]Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.
- 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 ] [ Designated as safety issue: No ]Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.
- 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 ] [ Designated as safety issue: No ]Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.
- 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 ] [ Designated as safety issue: No ]Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.
| Enrollment: | 55 |
| Study Start Date: | January 1991 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Lupron (leuprolide acetate)
Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.
Other Name: Lupron
|
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| Ages Eligible for Study: | up to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660010
Locations
| United States, Arizona | |
| Site Reference ID/Investigator# 46673 | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Site Reference ID/Investigator# 46671 | |
| San Francisco, California, United States, 94122 | |
| Site Reference ID/Investigator# 14921 | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Site Reference ID/Investigator# 14343 | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Site Reference ID/Investigator# 14341 | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Indiana | |
| Site Reference ID/Investigator# 14342 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 46672 | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Site Reference ID/Investigator# 46668 | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 14344 | |
| Hershey, Pennsylvania, United States, 17033 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Kristof Chwalisz, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott |
| ClinicalTrials.gov Identifier: | NCT00660010 History of Changes |
| Other Study ID Numbers: | M90-516 |
| Study First Received: | April 15, 2008 |
| Results First Received: | April 22, 2010 |
| Last Updated: | April 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
central precocious puberty CPP pediatrics suppression of LH Lupron leuprolide acetate |
depot formulation GnRHa GnRH agonist GNRH analog LH Tanner staging |
Additional relevant MeSH terms:
|
Puberty, Precocious Gonadal Disorders Endocrine System Diseases Leuprolide Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013