Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01252693
Eligibility Criteria:
Inclusion Criteria:
* Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
* Screening testosterone \> 1.5 ng/ml
* Life expectancy of at least 12 months
* ECOG score of ≤ 2
* Patient has reviewed and signed Informed consent form
* Patient understands and is willing to comply with the protocol
Exclusion Criteria:
* Any hormone therapy prior to study entrance
* Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
* History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
* History of hypersensitivity towards any components of the study drug
* History or presence of any other malignancy other than treated squamous cell /basal cell carcinoma of the skin within the last five years
* ECG at screening showing QTc \>450 ms, or family history of long QT syndrome
* Abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial
• - Has a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator
* Taking Class IA or Class III antiarrhythmic medication
* Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
* Has received investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of this trial
* Has previously participated in any Ozarelix trials
* Is part of an ongoing trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01252693
Study Brief:
Protocol Section:
NCT01252693