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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00119418
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women aged 45-58 with an adequate hot flash frequency severity score. Post-menopause is defined as amenorrhea for at least 12 months, or post-hysterectomy for more than one year with follicle-stimulating hormone levels greater than or equal to 40 mIU/mL and estradiol (E2) levels of less than or equal to 20 pg/mL, or greater than two months post oophorectomy.
* All subjects must be up to date with both pap and mammogram screening by the US Preventative Services Taskforce Guidelines for the length of the trial.
* All subjects on any prescription medication need the approval of their prescribing physician for participation in the trial.
Exclusion Criteria:
* Concurrent hot flash therapies (prescription medications including hormones, antidepressants, SERMs, gabapentin or over the counter supplements)
* Moderately severe disease state(s) or diseases that affect absorption/metabolism, or diseases that mimic menopausal hot flashes.
* Inability to swallow vitamin size pills
* Beck depression inventory score greater than 11
* Greater than 10 cigarettes per day
* Abnormal liver function
* Treated or untreated hypertension greater than 160/90.
* BMI greater than 36
* Inability to give consent or commit to the length of the trial
* Known hypersensitivity to ingredients
* Physician judgment
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
58 Years
Study:
NCT00119418
Study Brief:
Protocol Section:
NCT00119418