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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04743934
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Ability to take oral medication and be willing to adhere to the study regimen.
* Male age \>18 years.
* Histologically confirmed prostate cancer.
* Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy.
* Serum testosterone \<50 ng/dL.
* Serum AST and ALT less than 2 times upper limit of normal.
* Endorsed reduced sexual interest.
* Attempted intercourse.
* Current sexual partner.
* Was sexually active with partner within 6 months prior to ADT.
* No other antineoplastic therapy planned during study period.
* No active symptoms attributable to systemic prostate cancer.
Exclusion Criteria:
* Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone.
* Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors.
* Current symptoms attributable to active prostate cancer
* Moderate or heavy alcohol use (\>2 drinks/day)
* Concurrent moderate or strong CYP3A4 inhibitors
* Concurrently taking medication classified as a monoamine oxidase inhibitor.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04743934
Study Brief:
Protocol Section:
NCT04743934