Status and phase
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About
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.
Sex
Ages
Volunteers
Inclusion criteria
Biopsy proven NASH
If suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months.
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:
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:
Ability and willingness of subject or legal guardian/representative to provide informed consent.
Exclusion criteria
Pregnancy or Breast-Feeding
Continuous use of the following medications for more than 3 days within 30 days of study entry:
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
Surgery within the previous 3 months.
Any serious infectious, cardiac, pulmonary, or kidney disease
Hypersensitivity to Femarelle ®
Malignancy of the uterus or breast
Past thromboembolic event
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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