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Completed

NCT Number: NCT01215513

Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Hospital, Seoul, Anam-dong, Seongbuk-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
  • Has completed the 7-month main trial, FE200486 CS42

Exclusion criteria

  • Has been withdrawn/discontinued from the FE200486 CS42 trial
  • A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

Treatment and study plan

degarelix

Drug

Primary outcomes

  1. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

    Time frame: From baseline (day 0) to end of treatment (up to day 364)

    The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.

    ULN=upper limit of normal

  2. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    Time frame: From baseline (day 0) to end of treatment (up to day 364)

    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

  3. Number of Participants With Markedly Abnormal Values in ECG Variables

    Time frame: From baseline (day 0) to end of treatment (up to day 364)

    This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Secondary outcomes

  1. Serum Levels of Prostate Specific Antigen (PSA) Over Time

    Time frame: Day 0, day 196, day 280, and day 364

    PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring Pharmaceuticals Korea, Ltd.

Registry information

Official study title

An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2010
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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