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

To compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo
capsules on body composition and metabolic parameters in overweight men with acquired
hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL) following a 6 month diet and 15
month exercise program. Subjects must not have been treated with testosterone products in the
6 months prior to the study and must not ever have used testosterone products for a year or
longer.

Inclusion Criteria:

1. Overweight (BMI 30 to 42 kg/m2 inclusive) males age 18 to 60 inclusive

2. Waist circumference ≥ 40 inches (101.6 cm)

3. Previously or concurrently diagnosed as having secondary hypogonadism.

4. Must have 2 morning testosterone assessments at Visit 1, collected before 10 AM, 2-4
days apart, and both of which must be ≤ 300ng/dL.

5. LH >1.4 and < 9.4 mIU/mL (at Visit 1 only)

6. HbA1c ≤7.5

7. Stable weight for last 3 months (+/- 10 pounds)

8. Lives or works within 10 miles of the gym that will be used for the study

9. Must be fit enough to participate in the fitness program

10. Ability to complete the study in compliance with the protocol requirements

11. Ability to understand and provide written informed consent

Exclusion Criteria:

1. 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.

2. Use of testosterone, 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. Known hypersensitivity to Clomid

5. Allergy to soy, peanuts or latex

6. Chronic use of glucocorticoids (chronic use of inhaled or topical glucocorticoids is
acceptable)

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

8. A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or
presence of moderate alcohol use (>21 drinks per week)

9. 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

10. A hematocrit >54%

11. Presence or known history of hyperprolactinemia with or without a tumor (prolactin >20
ng/mL)

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

13. Current or history of breast cancer

14. Uncontrolled hypertension based on the Investigator's assessment at screening

15. History of bulimia nervosa or binge eating

16. Subject has (had) a lap band or undergone gastric bypass surgery

17. Subject has celiac disease or gluten intolerance

18. Subject has Type I diabetes

19. Subject 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

20. Enrolled and randomized (if applicable) in a previous enclomiphene study