The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Intervention: Androxal (enclomiphene citrate); Testosterone
Intervention description: capsule oral
1X a day 6 weeks; topical gel
1X a day 6 weeks
Intervention MeSH terms: Methyltestosterone; Enclomiphene; Clomiphene; Zuclomiphene; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will determine the effects of three doses of Androxal(enclomiphene citrate)on
      morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone
      (<350 ng/dL)after 6 weeks of continuous dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males between the ages of 18 and 65 years of age exhibiting morning
             testosterone ≤350 ng/dL.

          -  All clinical laboratory tests within normal ranges (any clinically significant
             deviation of laboratory results will require approval of sponsor)

          -  Ability to complete the study in compliance with the protocol

          -  Ability to understand and provide written informed consent

          -  Agreement to use a condom, and with a fertile female partner, another form of
             contraception.

          -  Agreement to provide a semen sample in the clinic

        Exclusion Criteria:

          -  Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3
             months prior to study

          -  Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen,
             anabolic steroid, DHEA, or herbal hormone products during the study

          -  Use of Clomid in the past year or during the study

          -  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. Newly diagnosed diabetics need to be treated for at
             least 48 hours before being enrolled in the study.

          -  A hematocrit ≥51 % 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

          -  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)

          -  History of breast cancer

          -  History of prostate cancer or a suspicion of prostate disease unless ruled out by
             prostate biopsy, or a PSA >3.6

          -  History of known hyperprolactinemia with or without a tumor

          -  Chronic use of medications use such as glucocorticoids

          -  Chronic use of narcotics

          -  Subjects known to be positive for HIV

          -  Subjects with end stage renal disease

          -  Subjects with cystic fibrosis (mutation of the CFTR gene)

          -  Subjects unable to provide a semen sample in the clinic

          -  Subject has a BMI >42 kg/m2