Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Intervention: Androxal
Intervention description: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 499.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men
      with secondary hypogonadism.
    

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