Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Intervention: Placebo; topical testosterone; Androxal
Intervention description: Placebo capsule 1x daily for 3 months; testosterone gel applied 1x daily for 3 months; Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene; Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The Purpose of the study is to determine the effects of Androxal on morning testosterone and
      reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less
      than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The
      effects of Testim versus placebo on reproductive status will also be examined. Study subjects
      must not be currently using a topical testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males between the ages of 21 and 65 years of age

          -  All clinical laboratory tests within normal ranges (any clinically significant
             deviation of laboratory results will require approval of sponsor)

          -  Previously or concurrently diagnosed as having secondary hypogonadism and confirmed
             morning testosterone <250ng/dL (two assessments at least 10 days apart)

          -  Ability to complete the study in compliance with the protocol

          -  Ability to understand and provide written informed consent

          -  Agreement to use double barrier contraception if with a fertile female partner

          -  Agreement to provide a semen sample in the clinic

        Exclusion Criteria:

          -  Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6
             months prior to study

          -  Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen,
             estrogen, anabolic steroid, DHEA, or herbal hormone products during the study

          -  Use of Clomid in the past year

          -  Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment
             at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control
             will be allowed into the study

          -  A hematocrit >50% or a hemoglobin >17 g/dL

          -  Clinically significant abnormal findings on screening examination

          -  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

          -  Known hypersensitivity to Clomid

          -  Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based
             on 0-4 scale or any trace of posterior subcapsular cataract)

          -  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

          -  Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
             primary hypogonadism, vasectomy, or tumors of the pituitary)

          -  Current or history of breast cancer

          -  Current or history of prostate cancer or a suspicion of prostate disease unless ruled
             out by prostate biopsy, or a PSA>3.6

          -  Presence or history of hyperprolactinemia with or without a tumor

          -  Chronic use of medications use such as glucocorticoids

          -  Subjects with cystic fibrosis (mutation of the CFTR gene)

          -  Subjects unable to provide a semen sample in the clinic

          -  Subject has a BMI >36 kg/m2