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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT04002661
Eligibility Criteria:
Inclusion Criteria:
* Men age 18 through 69 years old
* Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C)
* Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)
* Men with good erectile function as defined by IIEF greater than 22
* Men with normal testosterone and liver function values (may be on testosterone therapy)
* Men who are satisfied in their relationship or with their partners
* Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.
* Willing to give informed consent
Exclusion Criteria:
* Hypogonadal patients (less than 350 ng/dL)
* IIEF-EF less than 22
* CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor
* Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
* Men with normal to high libido
* Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.
* Men who are stressed or fatigued as determined by the PI
* Men with partners who have low libido as determined by the PI
* Men with pre-existing conditions that might predispose to hypertension
* Men who are not willing to meet the requirements for drinking alcohol during their participation in the study
* Men who are taking digoxin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT04002661
Study Brief:
Protocol Section:
NCT04002661