An open-label, multi-centre, extension study evaluation the long-term safety and tolerability of Degarelix one-month depots in patients with prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003814-40-HU

Enrollment

130

Registered

2004-11-09

Start date

2005-02-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer MedDRA version: 7.0 Level: pr t Classification code 10060862

Interventions

Product Name: Degarelix Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Degarelix CAS Number: 214766-78-6 Other descriptive name: FE 200486 Concentration unit

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: •Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. •Has completed the FE200486 CS12 study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Has been withdrawn from the FE200486 CS12 study

Design outcomes

Primary

Measure	Time frame
Main Objective: •To evaluate safety and tolerability during long-term treatment with degarelix one-month depots in prostate cancer patients.;Secondary Objective: •To evaluate the testosterone response during long-term treatment with degarelix one-month depots in prostate cancer patients. •To evaluate the PSA response during long-term treatment with degarelix one-month depots in prostate cancer patients. •To evaluate the time to disease progression (PSA progression, death from any cause, introduction of additional therapy related to the prostate cancer) during long-term treatment with degarelix one-month depots in prostate cancer patients. ;Primary end point(s): •Changes in clinical safety parameters (AEs, local tolerability, physical examination, vital signs, ECG and body weight). •Clinically significant changes in laboratory safety parameters (biochemistry, haematology and urialysis).	—

Measure

Time frame

Main Objective: •To evaluate safety and tolerability during long-term treatment with degarelix one-month depots in prostate cancer patients.;Secondary Objective: •To evaluate the testosterone response during long-term treatment with degarelix one-month depots in prostate cancer patients. •To evaluate the PSA response during long-term treatment with degarelix one-month depots in prostate cancer patients. •To evaluate the time to disease progression (PSA progression, death from any cause, introduction of additional therapy related to the prostate cancer) during long-term treatment with degarelix one-month depots in prostate cancer patients. ;Primary end point(s): •Changes in clinical safety parameters (AEs, local tolerability, physical examination, vital signs, ECG and body weight). •Clinically significant changes in laboratory safety parameters (biochemistry, haematology and urialysis).

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Countries

Germany, Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026