Trial record 2 of 2 for: degarelix AND CS06

Previous Study | Return to List | Next Study

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

This study has been completed.

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00117949

First received: June 30, 2005

Last updated: May 18, 2011

Last verified: May 2011

History of Changes

Results First Received: January 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Degarelix

Participant Flow

Hide 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 patients were followed until they met a pre-defined criterion for insufficient testosterone or prostate-specific antigen (PSA).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Participant Flow: Overall Study

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
STARTED	10 ^[1]	24	24	24
COMPLETED	0	0	0	0
NOT COMPLETED	10	24	24	24
Testosterone >1.0 ng/mL	10	18	17	15
Testosterone 0.5 - 1.0 ng/mL	0	1	3	2
Prostate-specific antigen increase >=25%	0	1	1	2
PSA increase >=10ng/mL	0	1	1	0
PSA reduction <=50%	0	2	2	4
Hepatic abnormalities	0	1	0	1

^[1]	Dose level terminated prematurely due to inadequate testosterone response

Baseline Characteristics

Hide Baseline Characteristics

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.
No text entered.

Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)
Total	Total of all reporting groups

Baseline Measures

Degarelix 40 mg

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Total

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Participants]

<=18 years

Between 18 and 65 years

>=65 years

Age
[Units: Years]
Mean (Standard Deviation)

72.0 (5.7)

77.5 (6.4)

75.9 (5.8)

74.7 (8.4)

75.6 (6.9)

Gender
[Units: Participants]

Female

Male

Race/Ethnicity, Customized
[Units: Participants]

Oriental/Asian

Black

Caucasian

Other

Gleason score ^[1]
[Units: Participants]

Unknown

2-4

5-6

7-10

^[1]	The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.

Stage of prostate cancer ^[1]
[Units: Participants]

Localized

Locally advanced

Metastatic

Not classifiable

^[1]	Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.

Body mass index ^[1]
[Units: Kilogram per square meter]
Mean (Standard Deviation)

26.70 (5.72)

26.61 (3.55)

27.22 (3.16)

26.64 (3.38)

26.70 (5.72)

^[1]	Body mass index is a measure of body fat based on height and weight.

Serum prostate-specific antigen levels
[Units: Nanogram per milliliter]
Median (Full Range)

9.30
(2.3 to 36.3)

13.40
(3.6 to 765)

9.10
(2.2 to 50.9)

6.40
(2.2 to 154)

9.35
(2.2 to 765)

Serum testosterone levels
[Units: Nanogram per milliliter]
Median (Full Range)

3.98
(2.29 to 5.31)

4.10
(1.79 to 8.53)

3.96
(2.02 to 7.22)

3.89
(1.79 to 8.53)

3.93
(1.79 to 8.53)

Time since prostate cancer diagnosis ^[1]
[Units: Days]
Mean (Standard Deviation)

851 (1077)

954 (1328)

1609 (1836)

1095 (1385)

1181 (1494)

^[1]	The mean number of days since a diagnosis of prostate cancer was made for the patients in each study group.

Weight
[Units: Kilogram]
Mean (Standard Deviation)

78.97 (11.73)

81.73 (11.50)

80.77 (12.83)

81.40 (14.36)

81.01 (12.61)

Outcome Measures

Show All Outcome Measures

1. Primary:

Time to Meet Insufficient Testosterone Response [ Time Frame: 3 months ]

Show Outcome Measure 1

2. Primary:

Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days [ Time Frame: 28 days ]

Show Outcome Measure 2

3. Secondary:

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). [ Time Frame: 1, 3, 7, 14, 21, 28, 42 days ]

Show Outcome Measure 3

4. Secondary:

Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days [ Time Frame: 3 months ]

Show Outcome Measure 4

5. Secondary:

Time to 50% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]

Show Outcome Measure 5

6. Secondary:

Time to 90% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]

Show Outcome Measure 6

7. Secondary:

Liver Function Tests [ Time Frame: 3 months ]

Show Outcome Measure 7

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide 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
No text entered.

More Information

Hide More Information

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: The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.

Results Point of Contact:

Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117949 History of Changes
Other Study ID Numbers:	FE200486 CS06
Study First Received:	June 30, 2005
Results First Received:	January 22, 2009
Last Updated:	May 18, 2011

To Top