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Official title Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes
ClinicalTrials.gov ID: NCT07548307
What this study is testing
- What it's testing
- Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 105, women only. Healthy volunteers may be eligible.
You may be able to join if
- Inclusion Participants must meet all the following 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 will determine sex-specific recruitment
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
See the full eligibility criteria
- Inclusion Participants must meet all the following 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 will determine sex-specific recruitment
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Peri or Post Menopausal women who have been experiencing hot flashes for the past 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 Individuals who report any of the following during screening may be excluded...
- Report being pregnant, trying to become 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 at a 7th grade level
- 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, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses...
- 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
- Lack of reliable daily access to the internet
- Currently taking a HRT medication
- Pre-Menopausal women
The study team makes the final eligibility decision.
Where it's taking place
- Del Mar, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 105 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Del Mar, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.