Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
To determine the effects of 12 months of treatment with Androxal on bone mineral density in
 men with secondary hypogonadism.
This study is a phase III single-blind placebo-controlled safety study with a 52 week active
 dosing period with Androxal. Safety will be assessed by physical and visual acuity exams,
 slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft
 tissue assessment (LST), and adverse event reporting. Results will be compared to an
 age-matched placebo group.
Inclusion Criteria:

 1. Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects)
 males age 18 to 60 inclusive

 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 <300ng/dL measured twice on separate days. One of the two TT
 levels must be confirmed at baseline. Subjects who fail this criterion will be
 enrolled in the placebo group.

 5. LH <9.4 mIU/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 or pelleted testosterone within 6 months prior to study (men
 currently on topical products may be enrolled in the study after a 7-day washout
 period)

 2. Use of 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 or diabetes mellitus based on the Investigator's assessment
 at baseline. Subjects treated for Type II diabetes will be allowed into the study.
 Newly diagnosed diabetics need to be treated for at least 48 hours before being
 enrolled in the study

 5. Clinically significant abnormal findings at screening (Visit 1), based on the
 Investigator's assessment.

 6. A hematocrit >54% or a hemoglobin >17 g/dL

 7. Clinically significant abnormal laboratory findings at baseline (Visit 2), based on
 the Investigator's assessment

 8. 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.

 9. Known hypersensitivity to Clomid

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

 11. Abnormal fundoscopy exam such as central retinal vein occlusion

 12. 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

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

 14. Current or history of breast cancer

 15. Subjects with a Z-score of <2

 16. Hyperparathyroidism, metabolic bone disease, previous fracture of the spine, recent
 chemotherapy, use of medications that may influence BMD (thyroid replacement therapy,
 immunosuppressive therapy, prednisone or antiepileptic drugs

 17. No intravenous or oral contrast agents within 7 days.

 18. Subject weighs >300 pounds (>136 kg)

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

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

 21. Chronic use of medications use such as glucocorticoids

 22. History of drug abuse or chronic narcotic use including methadone

 23. Subjects with known history of HIV and/or Hepatitis C

 24. Subjects with end stage renal disease

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

 26. Enrollment in a previous Androxal study