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:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT00537459
Eligibility Criteria:
Inclusion criteria:
* Body weight \>50kg
* Body Mass Index (BMI): 19-30
* Healthy men with long term (at least 6 months) symptoms of PE
* Erectile Dysfunction - (patients should have EF(Erectile Function) domain of IIEF(International Index of Erectile Function questionnaire \>26 or normal)
* No history of reduced sexual desire
* No history of significant psychiatric illness or currently active significant medical illness
* No SSRI's(Selective Serotonin Reuptake Inhibitors) use within the last 4 months
* No history of diabetes, renal or hepatic disease
* No significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis.
Exclusion criteria:
* Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction
* Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders
* Subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers
* Subject has received or is continuing to receive any treatment for PE (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start
* Subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00537459
Study Brief:
Protocol Section:
NCT00537459