Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

This is an interventional treatment trial for Secondary Hypogonadism Read More

Inclusion Criteria:

1. Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
2. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
3. Previously or concurrently diagnosed as having secondary hypogonadism characterized as having 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
4. LH < 9.4 mIU/mL (at Visit 1 only)
5. Sperm count ≥ 15 million per milliliter (assessed twice at least 48 hours apart)
6. Ability to complete the study in compliance with the protocol
7. Ability to understand and provide written informed consent
8. Agreement to provide a total of up to 6 semen sample in a sponsor-approved clinic on up to 6 separate occasions.

Exclusion Criteria:

1. Any prior use of testosterone treatments within the last 6 months
2. Use of 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) or Baseline, based on the Investigator's assessment
6. A hematocrit >54% or a hemoglobin >17 g/dL (sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with a high elevation)
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. Abnormal fundoscopy exam such as central retinal vein occlusion
11. 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
12. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
13. Current or history of breast cancer
14. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6
15. Presence or history of known hyperprolactinemia with or without a tumor
16. Chronic use of medications such as glucocorticoids
17. History of drug abuse or chronic narcotic use including methadone
18. A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week)
19. Subjects with known history of HIV and/or Hepatitis C
20. Subjects with end stage renal disease
21. History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal
22. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation
23. History of cerebrovascular disease
24. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
25. History of erythrocytosis or polycythemia
26. Subjects with cystic fibrosis (mutation of the CFTR gene)
27. Subjects unable to provide a semen sample in a sponsor-approved clinic
28. Enrollment in a previous Androxal study