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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01726127
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women between the ages of 40-50; premenopause is defined as regular menstrual cycles every 23-35 days
* Willing to be randomized and compliant to the 3 study groups (whole cruciferous vegetable intake, cruciferous supplement or placebo capsules)
* Able to give informed consent.
Exclusion Criteria:
* Urinary 2:16 \> or = 3.
* Current kidney or liver disease, adrenalectomy, or oophorectomy.
* Use of tobacco products within the preceding three months, illegal use of medications or use of illegal drugs or substances.
* Current use of antibiotics, cimetidine or black cohosh.
* Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen, or diabetes medication within the last three months.
* Women under a physician-directed diet or those with a strong dislike of Brassica vegetables.
* Presence of cancer in the last 5 years, with the exception of fully resected basal or squamous cell tumors.
* Participation in an investigational drug study in the last 30 days.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
50 Years
Study:
NCT01726127
Study Brief:
Protocol Section:
NCT01726127