Clinical trial: Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (NCT03933618)

Eligibility criteria:
Inclusion Criteria:

          1. Men age 18-70

          2. Baseline morning Testosterone 150-350 ng/dL x2

          3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0
             miU/mL, Prolactin 4-15 ng/mL

          4. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when
             an affirmative answer (''yes'') to either questions "Do you have a decreased sex
             drive/libido?" or "Are your erections less strong?" or any three other questions.10

          5. Body mass index (BMI) <40

          6. Sexual health inventory for men (SHIM) score >7 and <21. Patients are allowed to be
             taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline,
             however we will ask them to do the SHIM survey as if they were not taking this
             medication.

          7. Men must attempt to have at least four sexual encounters over each of the eight-week
             periods

          8. Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study

        Exclusion Criteria:

          1. Current or previous history of prostate cancer

          2. Previous or current androgen deprivation therapy for prostate cancer,

          3. Past surgical history of prostatectomy.

          4. History of testicular cancer.

          5. History of deep vein thrombosis (DVT) or blood dyscrasia

          6. History of breast cancer

          7. Men with past or current treatment for erectile dysfunction including MUSE
             (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or
             men who are on phosphodiesterase inhibitors will be allowed to be in the study but
             must stop their use at the screening visit.

          8. Chronic opioid use

          9. Use of steroids within the past 3 months, including prednisone and/or cortisone
             injections, and inhaled steroids. Topical steroid cream is acceptable.

         10. History of or current use of anabolic steroids, i.e. testosterone, (or any analog of
             testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or
             any growth promoters i.e. growth hormone itself or analogs of growth hormone

         11. History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet,
             estrogens

         12. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of
             wine or cocktail daily)

         13. Having started a new medication during the past three months which may interfere with
             the outcome measures of the study

         14. Polycythemia (HCT >52% )

         15. History of prostate specific antigen (PSA)> 4.0 ng/dl

         16. Hematocrit (HCT)< 36 %

         17. Liver function tests greater than 2 times upper normal limits or history of abnormal
             electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the
             investigator.

         18. Previous hypogonadal treatment within last 3 months. -
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 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