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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT00853606
Eligibility Criteria:
Inclusion Criteria:
* Successfully completed the entire treatment period in a qualifying study (TA-301 \[NCT00790751\] or TA-302 \[NCT00809471\]);
* Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
* Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
* Agree to make at least 4 attempts at intercourse each month through the course of this study;
* Agree not to use any other treatments for erectile dysfunction during participation in this study.
* Provide written informed consent;
* Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
* Subjects requiring treatment with an excluded medication.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00853606
Study Brief:
Protocol Section:
NCT00853606