Clinical trial: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism (NCT01534208)

Eligibility criteria:
Inclusion Criteria:

          1. Secondary hypogonadal males between the ages of 18 and 65

          2. Men currently using topical testosterone products should wash-out for at least 7 days
             before Visit 1.

          3. All clinical laboratory tests within normal ranges (any clinically significant
             deviation of laboratory results will require approval of sponsor)

          4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed
             with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men
             age 55-65

          5. LH < 15mIU/mL (at Visit 1 only)

          6. Ability to complete the study in compliance with the protocol

          7. Ability to understand and provide written informed consent.

        Exclusion Criteria:

          1. Use of an injectable pelleted testosterone within 6 months prior to study (men
             currently on topical testosterone products may be enrolled in the study after a 7-day
             washout period).

          2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase
             inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone
             products during the study

          3. Use of Clomid in the past year

          4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects
             treated for Type II diabetes will be allowed into the study.

          5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL

          6. Clinically significant abnormal findings on screening examination, based on the
             Investigator's assessment.

          7. Use of an investigational drug or product, or participation in a drug or medical
             device research study within 30 days prior to receiving study medication.

          8. Known hypersensitivity to Clomid

          9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based
             on 0-4 scale or any trace of posterior subcapsular cataract)

         10. Any condition which in the opinion of the investigator would interfere with the
             participant's ability to provide informed consent, comply with study instructions,
             possibly confound interpretation of study results, or endanger the participant if he
             took part in the study

         11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
             primary hypogonadism, or tumors of the pituitary)

         12. Current or history of breast cancer

         13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled
             out by prostate biopsy, or a PSA > 3.6

         14. Presence or history of known hyperprolactinemia with or without a tumor

         15. Chronic use of medications use such as glucocorticoids

         16. Chronic use of narcotics

         17. Subjects know to be positive for HIV

         18. End stage renal disease

         19. Subjects with cystic fibrosis (mutation of the CFTR gene)

         20. Enrollment in a previous Androxal study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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? Entailment