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A Study of Degarelix in Patients With Prostate Cancer

NCT00928434 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2016-12-13

Study results available
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Summary

The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Conditions

Interventions

DRUG

Degarelix

Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

DRUG

Degarelix

Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

DRUG

Leuprolide

Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928434 on ClinicalTrials.gov