A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

Exclusion Criteria

• •Any use of testosterone products (injectable, pelleted, transdermal or sublingual) in the 6 months prior to the study or any prior use of testosterone products for 12 months or longer at any time.
• •Use of testosterone, Clomid, 5α-reductase inhibitors, human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid, dehydroepiandrosterone (DHEA), or herbal hormone products during the study.
• •Use of Clomid in the past year.
• •Known hypersensitivity to Clomid.
• •Allergy to soy, peanuts or latex.
• •Chronic use of glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable).
• •History of drug abuse or chronic narcotic use including methadone.
• •A recent history of alcoholism or illegal substance or steroid abuse (\<2 years) or presence of moderate alcohol use (\>21 drinks per week).
• •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.
• •A hematocrit \>54%.
• •Presence or known history of hyperprolactinemia with or without a tumor (prolactin \>20 ng/mL).
• •Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a prostate specific antigen (PSA)\>3.6.
• •Current or history of breast cancer.
• •Uncontrolled hypertension based on the Investigator's assessment at screening.
• •History of bulimia nervosa or binge eating.
• •Participant has (had) a lap band or undergone gastric bypass surgery.
• •Participant has celiac disease or gluten intolerance.
• •Participant has Type I diabetes.
• •Participant has 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.
• •Enrolled and randomized (if applicable) in a previous enclomiphene study.