Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT00667446

First received: April 24, 2008

Last updated: January 8, 2014

Last verified: January 2014

History of Changes

Results First Received: October 16, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Precocious Leuprolide Acetate Luteinizing Hormone (LH) Gonadotrophin-releasing Hormone Agonist (GnRHa) Tanner Staging Depot Formulation Suppression of LH Central Precocious Puberty (CPP) Gonadotrophin-releasing Hormone (GnRH) Lupron GnRH Analog Pediatrics Central Precocious Puberty
Intervention:	Drug: Leuprolide Acetate 3 Month Depot

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.

Reporting Groups

	Description
Leuprolide Acetate 3M Depot 11.25 mg	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
Leuprolide Acetate 3M Depot 30 mg	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.

Participant Flow for 2 periods

Period 1: Treatment Period (36 Months)

	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
STARTED	34	38
COMPLETED	11	13
NOT COMPLETED	23	25
Ready to enter puberty based on age	13	15
Other	2	2
Personal reasons	2	2
Withdrawal by Subject	0	4
Not Adequately Suppressed on Therapy	3	0
Lost to Follow-up	1	0
Protocol Violation	1	1
Therapeutic Failure	1	1

Period 2: Safety Follow-up Period (12 Weeks)

	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg
STARTED	28	26
COMPLETED	28	25
NOT COMPLETED	0	1
No Longer Needed Treatment	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received at least 1 dose of study drug in this extension study.

Reporting Groups

	Description
Leuprolide Acetate 3M Depot 11.25 mg	Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Leuprolide Acetate 3M Depot 30 mg	Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Total	Total of all reporting groups

Baseline Measures

	Leuprolide Acetate 3M Depot 11.25 mg	Leuprolide Acetate 3M Depot 30 mg	Total
Number of Participants [units: participants]	34	38	72
Age [units: years] Mean ± Standard Deviation	8.50 ± 1.71	8.45 ± 1.52	8.47 ± 1.60
Gender [units: participants]
Female	32	33	65
Male	2	5	7

Outcome Measures

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1. Primary:

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone [ Time Frame: Day 1, Months 6, 12, 24, and 36 ]

Show Outcome Measure 1

2. Secondary:

Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1) [ Time Frame: Day 1, Months 3, 6, 9, 12, and 24 ]

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3. Secondary:

Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2) [ Time Frame: Months 6, 9, 12, 24, 30, and 36 ]

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4. Secondary:

Percentage of Male Participants With Suppression of Basal Testosterone [ Time Frame: Day 1, Months 3, 6, 9, 12, 24, 30, and 36 ]

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5. Secondary:

Mean Peak-stimulated Luteinizing Hormone Concentration by Visit [ Time Frame: Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36 ]

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6. Secondary:

Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development) [ Time Frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ]

Show Outcome Measure 6

7. Secondary:

Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) [ Time Frame: Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36 ]

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8. Secondary:

Change From Baseline in Growth Rate [ Time Frame: Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36 ]

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9. Secondary:

Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age [ Time Frame: Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: AbbVie, (prior sponsor, Abbott)
phone: 800-633-9110

No publications provided by AbbVie

Publications automatically indexed to this study:

Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P. 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. J Clin Endocrinol Metab. 2014 Sep;99(9):3153-9. doi: 10.1210/jc.2013-4471. Epub 2014 Jun 13.

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
Results First Received:	October 16, 2013
Last Updated:	January 8, 2014
Health Authority:	United States: Food and Drug Administration

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