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 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 1:37 AM
NCT ID:
NCT07117994
Eligibility Criteria:
Inclusion Criteria:
* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
* Assigned sex at birth is female
* Resides in the United States
* Identifies menstrual status as perimenopausal
* Has the opportunity for at least 30% improvement in their primary health outcome
* Indicates having peri-menopausal issues for 3 months or longer
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Exclusion Criteria:
* Individuals who report any of the following during screening will be excluded from participation:
* Reports being pregnant or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* Reports current enrollment in another clinical trial
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
* NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
* Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
* Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk to participants
* Reports an allergy to and/or disinterest in any of the possible study product ingredients
* Lack of reliable daily access to the internet
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
105 Years
Study:
NCT07117994
Study Brief:
Protocol Section:
NCT07117994