Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease

Inclusion Criteria:

1. Biopsy proven NASH

2. If suffering from diabetes may be treated by up to 2 oral medications, with stabledoses for 2 months.

3. If participating in sexual activity that could lead to pregnancy, the study volunteermust agree that two reliable methods of contraception will be used simultaneouslywhile receiving the protocol-specified medication and for 1 month after stopping themedication. NOTE: Hormonal-based methods alone are not sufficient. At least two of the followingmethods MUST be used appropriately unless documentation of menopause, sterilization,or azoospermia is present:

• Condoms (male or female) with or without a spermicidal agent. - Condoms arerecommended because their appropriate use is the only contraception methodeffective for preventing HIV transmission

• Diaphragm or cervical cap with spermicide

• IUD

• Hormonal-based contraception Study subjects who are not of reproductive potential (girls who have not reachedmenarche or women who have been post-menopausal for at least 24 consecutive months orhave undergone hysterectomy and/or bilateral oophorectomy are eligible withoutrequiring the use of contraceptives. Written or oral documentation communicated byclinician or clinician's staff is required by one of the following:

• Physician report/letter

• Operative report or other source documentation in the patient record (alaboratory report of azoospermia is required to document successful vasectomy)

• Discharge summary

• Laboratory report of azoospermia

• FSH measurement elevated into the menopausal range as established by thereporting laboratory.

4. Ability and willingness of subject or legal guardian/representative to provideinformed consent.

Exclusion Criteria:

1. Pregnancy or Breast-Feeding

2. Continuous use of the following medications for more than 3 days within 30 days ofstudy entry:

• Immunosuppressives

• Immune modulators

• Systemic glucocorticoids

• Anti-neoplastic agents

3. Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements.

4. Serious illness requiring systemic treatment and/or hospitalization within 30 daysprior to entry.

5. Surgery within the previous 3 months.

6. Any serious infectious, cardiac, pulmonary, or kidney disease

7. Hypersensitivity to Femarelle ®

8. Malignancy of the uterus or breast

9. Past thromboembolic event