Spots Global Cancer Trial Database for An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer
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Trial Identification
Brief Title: An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer
Official Title: An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study ID: NCT02015871
Conditions
Interventions
Study Description
Brief Summary: This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Peking University People's Hospital (there may be multiple sites in this country), Beijing, Beijing, China
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
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