Trial record 4 of 25 for:
"Precocious puberty"
Safety Extension Study Of Lupron Depot In The Treatment Of Central Precocious Puberty
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00667446
First received: April 24, 2008
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
| Condition | Intervention | Phase |
|---|---|---|
|
Precocious Leuprolide Acetate Luteinizing Hormone (LH) Gonadotrophin-releasing Hormone Agonist(GnRHa) Tanner Staging Depot Formulation Suppression of LH CPP Gonadotrophin-releasing Hormone (GnRH) Lupron GnRH Analog Pediatrics Central Precocious Puberty |
Drug: Leuprolide acetate 11.25 mg Drug: Leuprolide acetate 30 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With 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 AbbVie:
Primary Outcome Measures:
- Suppression of peak-stimulated luteinizing hormone concentrations (< 4 mIU/mL). [ Time Frame: Day 1, Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Suppression of sex steroids (estradiol < 20 pg/mL in girls and testosterone < 30 ng/dL in boys). [ Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]Basal
- Peak stimulated luteinizing hormone concentrations. [ Time Frame: Day 1, Months 6, 12, 24, and 36 ] [ Designated as safety issue: Yes ]
- Suppression of the physical signs of puberty. [ Time Frame: Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]
- Change from baseline (from the lead-in study) in growth rate. [ Time Frame: Day 1, Months 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: Yes ]
- The ratio of change from baseline (from the lead-in study) in bone age/change from baseline in chronological age. [ Time Frame: Day 1, Months 12, 24, and 36 ] [ Designated as safety issue: Yes ]
| Enrollment: | 73 |
| Study Start Date: | December 2008 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Leuprolide acetate 11.25 mg |
Drug: Leuprolide acetate 11.25 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Other Name: ABT-818, leuprolide acetate, Lupron
|
| Experimental: Leuprolide acetate 30 mg |
Drug: Leuprolide acetate 30 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Other Name: ABT-818, leuprolide acetate, Lupron
|
Detailed Description:
Approximately 70 subjects with Central Precocious Puberty from approximately 25 sites who completed the treatment period of the lead-in study, L-CP07-167, will enter this 36 month open-label extension study. This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Subjects will receive a total of twelve (12) injections of the same treatment they received in the lead-in study, either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject completed the Treatment Period of the lead-in study, L-CP07-167, and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone <4 mIU/mL at the Month 6 study visit of the lead-in study.
- Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study.
- Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry.
- In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator.
Exclusion Criteria:
- Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
- Bone age >/=14 years for girls and >/=15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results)
- Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
- Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
- Current therapy with medroxyprogesterone acetate.
- Current therapy with growth hormone.
- Current therapy with insulin-like growth factor-1 (IGF-1).
- Current use of an estrogen preparation.
- Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
- Subject has a positive pregnancy test.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667446
Locations
| United States, Alabama | |
| Site Reference ID/Investigator# 13521 | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Site Reference ID/Investigator# 14922 | |
| Long Beach, California, United States, 90806 | |
| Site Reference ID/Investigator# 26043 | |
| Los Angeles, California, United States, 90027 | |
| Site Reference ID/Investigator# 20802 | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Site Reference ID/Investigator# 22425 | |
| Greenwood Village, Colorado, United States, 80111 | |
| United States, Florida | |
| Site Reference ID/Investigator# 18181 | |
| Jacksonville, Florida, United States, 32207 | |
| Site Reference ID/Investigator# 26364 | |
| Pensacola, Florida, United States, 32504 | |
| United States, Indiana | |
| Site Reference ID/Investigator# 26983 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Site Reference ID/Investigator# 20821 | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Minnesota | |
| Site Reference ID/Investigator# 23643 | |
| Minneapolis, Minnesota, United States, 55455 | |
| Site Reference ID/Investigator# 23502 | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 14121 | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Oklahoma | |
| Site Reference ID/Investigator# 23802 | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Site Reference ID/Investigator# 13324 | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 16506 | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Washington | |
| Site Reference ID/Investigator# 14024 | |
| Seattle, Washington, United States, 98104 | |
| Puerto Rico | |
| Site Reference ID/Investigator# 23182 | |
| Bayamon, Puerto Rico, 00960 | |
| Site Reference ID/Investigator# 21721 | |
| Ponce, Puerto Rico, 00717-2116 | |
| Site Reference ID/Investigator# 23082 | |
| San Juan, Puerto Rico, 00936-8344 | |
| Site Reference ID/Investigator# 25908 | |
| San Juan, Puerto Rico, 18637 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Peter Bacher, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00667446 History of Changes |
| Other Study ID Numbers: | L-CP07-177 |
| Study First Received: | April 24, 2008 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Central Precocious Puberty GnRH analog Luteinizing hormone (LH) Gonadotrophin-releasing hormone agonist(GnRHa) Suppression of LH Gonadotrophin-releasing hormone (GnRH) |
CPP Leuprolide acetate Depot formulation Lupron Tanner staging Pediatrics |
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 23, 2013