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The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

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Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Degarelix
Drug: Leuprolide 7.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00295750
FE200486 CS21

Details and patient eligibility

About

The study was a three-arm, active-control, multi-centre, parallel group study.

Enrollment

620 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

  • Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Baseline testosterone >1.5 ng/mL.
  • Life expectancy of at least 12 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

620 participants in 3 patient groups

degarelix 240/160 mg
Experimental group
Description:
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
Treatment:
Drug: Degarelix
Drug: Degarelix
degarelix 240/80 mg
Experimental group
Description:
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
Treatment:
Drug: Degarelix
Drug: Degarelix
Leuprolide 7.5 mg
Active Comparator group
Description:
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Treatment:
Drug: Leuprolide 7.5 mg

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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