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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01269320
Recruitment Status : Withdrawn (Sponsors decision)
First Posted : January 4, 2011
Last Update Posted : August 28, 2012
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE January 3, 2011
First Posted Date  ICMJE January 4, 2011
Last Update Posted Date August 28, 2012
Study Start Date  ICMJE January 2012
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease
Official Title  ICMJE Not Provided
Brief Summary

This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome.

Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.

Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nash
Intervention  ICMJE Drug: Femarelle
Study treatment will consist of Femarelle, two 530mg oral tablets (equivalent to 322 mg of DT56a and 108 mg of Linum Usitatissimum extract each) twice a day for 90 days
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 27, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2011)
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Biopsy proven NASH
  2. If suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months.
  3. If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication.

    NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:

    • Condoms (male or female) with or without a spermicidal agent. - Condoms are recommended because their appropriate use is the only contraception method effective 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 reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:

    • Physician report/letter
    • Operative report or other source documentation in the patient record (a laboratory 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 the reporting laboratory.
  4. Ability and willingness of subject or legal guardian/representative to provide informed consent.

Exclusion Criteria:

  1. Pregnancy or Breast-Feeding
  2. Continuous use of the following medications for more than 3 days within 30 days of study entry:

    • Immunosuppressives
    • Immune modulators
    • Systemic glucocorticoids
    • Anti-neoplastic agents
  3. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  4. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01269320
Other Study ID Numbers  ICMJE 0172-10-HMO-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP