StressNCT07117994
Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues
A study testing Radicle Revive Active Study Product 1 in people with Stress and Menopause, run by Radicle Science at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 to 105 years, women onlyHealthy volunteers can take part
- What is being tested?
- Radicle Revive Active Study Product 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 105 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Radicle Science, Inc
Del Mar, California, 92014-2605
About this study
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
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
Read the detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants (1) are females, (2) have peri-menopausal-related health issues for 3 months or longer, (3) have the opportunity to improve by at least 30% in the primary outcome, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and ag who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Being tested
- Radicle Revive Placebo Control Form 1, Radicle Revive Active Study Product 1
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radicle Revive Placebo Control Form 1Dietary supplement
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Radicle Revive Active Study Product 1Dietary supplement
Participants will use their Radicle Revive Active Study Product 1 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Radicle Revive Placebo Control Form 1 Receives: Dietary Supplement: Radicle Revive Placebo Control Form 1 |
| Active Product 1 | Experimental | Radicle Revive Active Study Product 1 Receives: Dietary Supplement: Radicle Revive Active Study Product 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress
Change in perceived stress: Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Measured: 6 weeks
Secondary outcomes (7)
Change in General Menopausal Health
Change in other menopausal health issues: Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
Measured: 6 weeks
Change in Sleep Disturbance
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
Measured: 6 weeks
Change in Fatigue
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Measured: 6 weeks
Minimal clinically important difference (MCID) in perceived stress
Likelihood of experiencing minimal clinically important difference in perceived stress, as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Measured: 7 weeks
Minimal clinically important difference (MCID) in menopausal health issues
Likelihood of experiencing minimal clinically important difference in menopausal health issues score assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
Measured: 7 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Measured: 7 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start5 Aug 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117994
- Sponsor's protocol ID
- RADX_P_2414_VPH
- Status last verified
- Jul 2025
- First submitted
- 5 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07117994
- Acronym / sponsor ID
- RADX_P_2414_VPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants (1) are females, (2) have peri-menopausal-related health issues for 3 months or longer, (3) have the opportunity to improve by at least 30% in the primary outcome, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and ag who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be stratified then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Radicle Revive Placebo Control Form 1Radicle Revive Placebo Control Form 1 |
| Active Product 1 | Experimental | Dietary Supplement: Radicle Revive Active Study Product 1Radicle Revive Active Study Product 1 |
Who may qualify
- Ages
- 40 to 105 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radicle Revive Placebo Control Form 1Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 1 |
| Radicle Revive Active Study Product 1Participants will use their Radicle Revive Active Study Product 1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1 |
Primary outcome
Change in Perceived Stress
Time frame: 6 weeks
Change in perceived stress: Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
7 secondary outcomes
Change in General Menopausal Health
Time frame: 6 weeks
Change in Sleep Disturbance
Time frame: 6 weeks
Change in Fatigue
Time frame: 6 weeks
Minimal clinically important difference (MCID) in perceived stress
Time frame: 7 weeks
Minimal clinically important difference (MCID) in menopausal health issues
Time frame: 7 weeks
Minimal clinically important difference (MCID) in fatigue
Time frame: 7 weeks
Minimal clinically important difference (MCID) in sleep
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hewlings principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radicle Revive Active Study Product 1 in people with Stress and Menopause, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.