Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Has given written consent before 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 had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.
You may not be if
Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
Requires hormonal therapy for neoadjuvant purposes.
Requires treatment with any other drug modifying the testosterone level or function.
Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
Has hypersensitivity towards any component of the investigational product.
Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
