A Study of Leuprolide to Treat Prostate Cancer - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: Leuprolide acetate - Formulation A Drug: Leuprolide acetate - Formulation B

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The enrollment of subjects with Formulation A occurred sequentially before the enrollment of subjects with Formulation B.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Formulation A and Formulation B treatment groups were enrolled sequentially. All analyses and summaries were conducted separately for both treatment groups.

Reporting Groups

	Description
Leuprolide Acetate - Formulation A	Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
Leuprolide Acetate - Formulation B	Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.

Participant Flow: Overall Study

	Leuprolide Acetate - Formulation A	Leuprolide Acetate - Formulation B
STARTED	151 ^[1]	159 ^[1]
COMPLETED	134	114
NOT COMPLETED	17	45

[1]	Separate groups of subjects received Formulation A and B and data were not compared between groups.

Baseline Characteristics

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Reporting Groups

	Description
Leuprolide Acetate - Formulation A	Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
Leuprolide Acetate - Formulation B	Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.

Baseline Measures

	Leuprolide Acetate - Formulation A	Leuprolide Acetate - Formulation B	Total
Number of Participants [units: participants]	151	159	310
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	18	33	51
>=65 years	133	126	259
Gender [units: participants]
Female	0	0	0
Male	151	159	310
Region of Enrollment [units: participants]
United States	151	159	310

Outcome Measures

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1. Primary:

Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint. [ Time Frame: Week 4 to Week 48 ]

Show Outcome Measure 1

2. Primary:

Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted [ Time Frame: Week 4 to Week 48 ]

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3. Primary:

Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned [ Time Frame: Week 4 to Week 48 ]

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4. Secondary:

Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population [ Time Frame: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit ]

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5. Secondary:

Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population [ Time Frame: Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit ]

Show Outcome Measure 5

6. Secondary:

Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population [ Time Frame: Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose) ]

Show Outcome Measure 6

7. Secondary:

Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population [ Time Frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) ]

Show Outcome Measure 7

8. Secondary:

Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population [ Time Frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) ]

Show Outcome Measure 8

9. Secondary:

Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population [ Time Frame: Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose) ]

Show Outcome Measure 9

10. Secondary:

Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population [ Time Frame: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit ]

Show Outcome Measure 10

11. Secondary:

Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population [ Time Frame: Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit ]

Show Outcome Measure 11

Serious Adverse Events

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Other Adverse Events

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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: Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

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
Treatment with Formulation B was prematurely discontinued as testosterone was not adequately suppressed to <= 50 ng/dL or escapes from suppression occurred. Subjects who had not received dose 2 of Formulation B were discontinued after Week 24.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Kristof Chwalisz, MD, PhD Therapeutic Area Head, Abbott
ClinicalTrials.gov Identifier:	NCT00626431 History of Changes
Other Study ID Numbers:	L-PC07-169
Study First Received:	February 20, 2008
Results First Received:	August 20, 2010
Last Updated:	July 15, 2011
Health Authority:	United States: Food and Drug Administration