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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03038867
Eligibility Criteria:
Inclusion Criteria:
* Healthy men aged 18-65 years old;
* normal or borderline semen analysis (sperm concentration \> 10 million/mL, sperm motility \> 30%, sperm morphology \> 3%);
* willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
* capable of providing semen sample.
Exclusion Criteria:
* Clinically detected varicocele;
* oligoasthenoteratospermia or azoospermia on semen analysis;
* ongoing attempts to initiate pregnancy;
* current sexual dysfunction (classified as moderate or worse on IIEF);
* history of seizure disorder;
* history of previous chemotherapy or radiation therapy;
* current psychiatric history or history of bipolar disorder;
* family history of bipolar disorder, depression, or suicide;
* use of any psychotropic medications or anticonvulsants;
* use of sleeping pills more than once per week;
* use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;
* use of medications which may affect hormone measures and/or sexual function;
* inability to read, follow instructions, or complete questionnaires in English;
* consumption of tobacco or illicit drugs;
* consumption of \>2oz of alcohol daily.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03038867
Study Brief:
Protocol Section:
NCT03038867