Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT01269320
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01269320
Study Brief:
Protocol Section:
NCT01269320