Clinical trial: Hypoactive Sexual Desire Disorder in Males (10-18-40-13) (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
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction