Clinical trial: Psychological Outcomes in Isolated GnRH Deficiency (NCT02356172)

Eligibility criteria:
-  ELIGIBILITY CRITERIA FOR IGD PATIENTS:

        INCLUSION CRITERIA:

        Males or females with clinical findings consistent with IGD who are greater than or equal
        to 18 years old and treated with hormone replacement therapy for IGD at the full adult
        replacement dose for at least 3 months. Clinical findings of IGD will be confirmed by a
        nurse or physician associated with this protocol, and include: clinical presentation
        consistent with a diagnosis of IGD, such as delayed, incomplete, or absent pubertal
        development, and a record of serum hormone levels demonstrating low total testosterone
        (males) or estradiol (females) in association with low or inappropriately normal
        gonadotropin levels in a clinic note or history and physical, and individuals with records
        demonstrating failure to undergo normal puberty. Anosmia may or may not be present. Since
        IGD presents as a phenotypic spectrum, there are no specific exclusion criteria for this
        study, except as noted below.

        EXCLUSION CRITERIA:

          -  Patients with a diagnosis of IGD who are <18 years old;

          -  Patients with a diagnosis of IGD who are not on a full adult replacement dose of sex
             hormone therapy for at least 3 months;

          -  Patients who do not have a diagnosis of IGD as indicated by the inclusion criteria
             above;

          -  Patients without access to a computer connected to the internet;

          -  Patients who cannot read, write, and understand English at an eighth grade level or
             above.

        ELIGIBILITY CRITERIA FOR HEALTHY CONTROLS:

        INCLUSION CRITERIA:

        Healthy males or females who are greater than or equal to 18 years old.

        EXCLUSION CRITERIA:

          -  Subjects with any chronic medical condition, other than seasonal/environmental
             allergies;

          -  Subjects with a BMI < 18.5 or > 29.9;

          -  Subjects with prior history of abnormal pubertal development, infertility, or anosmia;

          -  Subjects with a family history of IGD;

          -  Subjects without access to a computer connected to the internet;

          -  Subjects who cannot read, write, and understand English at an eighth grade level or
             above.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 200 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