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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00301405
Eligibility Criteria:
Inclusion Criteria:
1. Male subjects aged 18 and older.
2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies
3. Subjects with a minimum score of 15 on the CPSI.
4. Male subjects must give written informed consent.
5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to include:
* He understands and can reliably carry out all instructions.
* He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program.
* He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug
* He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy.
* He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy.
* He agrees NOT to be a sperm or blood donor while being treated with thalidomide -
Exclusion Criteria:
1. Subjects who are female.
2. Subjects with a documented positive urine culture (\>100,000 CFU/mL) within the past six months
3. Subjects with duration of symptoms less than three months
4. Subjects with active genital infections
5. Subjects with prior urologic surgeries
6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate
7. Subjects having received prior radiation to the abdominal or pelvic area
8. Subjects with known bladder or ureteral calculi
9. Subjects unable to complete a voiding diary
10. Subjects diagnosed with neuropathy
11. Subjects with neutropenia
12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state
13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program
14. Subjects with orthostatic hypotension
15. Subjects with known malignancies in the last 2 years.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00301405
Study Brief:
Protocol Section:
NCT00301405