ACTIVE_NOT_RECRUITING

Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Peri-Menopausal Health Issues

Official Title

Radicle Revive™ 24_VPH: 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 Peri-Menopausal Health Issues

Quick Facts

Study Start:2025-08-05

Study Completion:2026-08-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07117994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 105 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Susan Hewlings

PRINCIPAL_INVESTIGATOR

Radicle Science Inc.

Study Locations (Sites)

Radicle Science, Inc

Del Mar, California, 92014-2605

United States

Collaborators and Investigators

Sponsor: Radicle Science

Susan Hewlings, PRINCIPAL_INVESTIGATOR, Radicle Science Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05

Study Completion Date2026-08-05

Study Record Updates

Study Start Date2025-08-05

Study Completion Date2026-08-05

Terms related to this study

Additional Relevant MeSH Terms

Stress
Menopause
Fatigue
Sleep