Clinical trial: Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration (NCT01880086)

Eligibility criteria:
Inclusion Criteria:

          -  Male

          -  18 years to 65 years

          -  Low testosterone as defined by criteria (serum total testosterone <350 ng/dl in men
             <55 years, <300 ng/dl in men 55-65 years)

          -  EITHER taking opioid pain medication (see A below) OR planning to start new pain
             medication regimen (see B below)

          -  A) EITHER continuous opioid treatment for chronic nonmalignant pain for >=6 months
             receiving one of several specified opioid regimens for the past 1 month (including
             >=20 mg/day of oral methadone, >=30 mg/day of oral sustained release oxycodone, >=30
             mg/day of oral morphine sulfate, >=6 mg/day of oral dilaudid or >= 8 mg/day of
             dilaudid ER, or >=25 mcg/hr of transdermal fentanyl or buprenorphine, or intrathecal
             morphine pump)

          -  B) OR the pain management physician is planning to start pain medication (opioid or
             non-opioid pain therapy) but you have not received it yet. If this is the case, your
             testosterone will be checked before starting and during 1 month of pain therapy to
             determine if you have low testosterone to qualify to begin medication (clomiphene or
             placebo) treatment in this study.

          -  BMI (20-35 kg/m2)

          -  Presence of clear secondary hypogonadism with hypogonadal symptoms and low total
             testosterone level (confirmed with morning testosterone level <= 350 ng/dL for men age
             >= 55 and <= 300ng/dl for men age 55-65) or total testosterone <=200 ng/dl (regardless
             of symptoms). Additionally luteinizing hormone (LH) should be <15 mIU
             (milli-International unit )/mL (at baseline only). Symptoms of hypogonadism include
             fatigue, decreased energy level/endurance, depressed mood, decreased libido, erectile
             dysfunction.

          -  Chronic nonmalignant pain etiology includes rheumatoid arthritis, osteoarthritis,
             spinal stenosis, polymyalgia, complex region pain syndrome I and II, neurinoma,
             phantom limb pain, neuropathic pain of other origin, scoliosis, neck pain, failed back
             surgery, or chronic pancreatitis.

          -  All patients must have ability to complete the study in compliance with the protocol,
             and the ability to understand and provide written informed consent.

        Exclusion Criteria:

          -  Chronic pain of malignant etiology (cancer-related)

          -  Preexisting testosterone deficiency

          -  Concomitant use of medication that could interfere with testosterone levels including
             antidepressant medication, spironolactone, cimetidine, clomiphene (use in the past 1
             year), human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid,
             5-alpha-reductase inhibitors such as finasteride, dehydroepiandrosterone (DHEA),
             testosterone therapy (topical testosterone within 7 days of study, injectable
             testosterone within 6 months of study),

          -  Uncontrolled hypertension

          -  Clinically significant abnormal findings on screening examination based on the
             Investigator's assessment

          -  Known hypersensitivity to clomiphene

          -  Symptomatic cataracts

          -  Presence or history of known hyperprolactinemia with or without a tumor

          -  End-stage renal disease

          -  Any contraindication to testosterone supplementation therapy

          -  Absolute contraindications to hormone supplementation therapy which include active
             prostate cancer (or suspicion of prostate disease unless ruled out by biopsy),
             prostatic specific antigen (PSA)>=3.6, breast cancer, hematocrit>=51% (hemoglobin>=17
             g/dL), uncontrolled congestive heart failure (CHF), myocardial infarction, acute
             coronary event, unstable angina, coronary revascularization procedure in the preceding
             6 months, untreated obstructive sleep apnea, high risk of prostate cancer (ethnicity
             or family history), or severe lower urinary tract symptoms (AUA symptom score>19).
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? Contradiction