Evaluating health and wellness products for menopausal health
Radicle Revive™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Menopausal Health Issues
This study is testing whether certain health and wellness products can help women aged 21 and older who are dealing with menopausal symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | Female |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT06749288 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial investigates the effects of health and wellness products on hormonal health and related outcomes in women experiencing menopausal issues. Participants will be women aged 21 and older who have had menopausal health issues for at least three months and are willing to use the study products without knowing their identities. Data will be collected electronically over a seven-week period, with assessments at baseline, during the study, and at the end. The study aims to provide insights into the effectiveness of these products in improving menopausal symptoms.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older residing in the U.S. with menopausal health issues for three months or longer.
Not a fit: Patients who are pregnant, breastfeeding, or have significant health concerns such as liver or kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of menopausal symptoms and enhance the quality of life for women experiencing these issues.
How similar studies have performed: While similar studies have explored health products for menopausal symptoms, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities * Resides in the United States * Endorses less pain as a primary desire * Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product * 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: * reports being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * The calculated validated health survey (PRO) score during enrollment represents less than mild severity * Reports a diagnosis of liver or kidney disease * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Reports current enrollment in a clinical trial * Lack of reliable daily access to the internet * Reports current or recent (within 3 months) use of chemotherapy or immunotherapy * Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO
Where this trial is running
Del Mar, California
- Radicle Science, Inc — Del Mar, California, United States (Recruiting)
Study contacts
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 760-281-3898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.