MenopauseNCT06749288
Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes
A study testing Radicle Revive Active Study Product 4.1 Usage in people with Menopause and Sleep Disturbance, 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 menopausal health issues Read more about this study
- Who is it for?
- Ages 21 to 105 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Sleep Disturbance, Anxiety
- What is being tested?
- Radicle Revive Active Study Product 4.1 Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jul 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 21 to 105 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
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 menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, 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 women 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.
- Conditions
- Menopause, Sleep Disturbance, Anxiety, Depression, Cognitive Function, Fatigue
- Being tested
- Radicle Revive Placebo Control Form 4.1, Radicle Revive Active Study Product 4.1 Usage
- Medical subject headings
- Parasomnias, Anxiety Disorders, Depression, 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 4.1Dietary supplement
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Radicle Revive Active Study Product 4.1 UsageDietary supplement
Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control 4.1.0 | Placebo comparator | Revive product form 4.1 - control Receives: Dietary Supplement: Radicle Revive Placebo Control Form 4.1 |
| Active product 4.1.1 | Experimental | Revive product form 4.1 - active product 1 Receives: Dietary Supplement: Radicle Revive Active Study Product 4.1 Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Measured: 6 weeks
Change in feelings of depression
Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)
Measured: 6 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)
Measured: 6 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)
Measured: 6 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)
Measured: 6 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; with higher scores corresponding to more severe sleep disturbance)
Measured: 6 weeks
Change in fatigue
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)
Measured: 6 weeks
Change in feelings of depression
Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)
Measured: 6 weeks
Change in fatigue
Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)
Measured: 6 weeks
Change in Pain Interference
Mean difference in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)
Measured: 6 weeks
Change in pain intensity
Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Measured: 6 weeks
Change in interest in sexual activity
Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)
Measured: 6 weeks
Secondary outcomes (14)
Change in other menopausal health issues
Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 10 - 48; where higher is more severe menopausal health issues)
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 4a (4-20; where lower scores indicate less anxiety).
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 8a (8-40; where lower scores indicate less anxiety).
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of depression
Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 4a (4-20; where lower scores indicate less depression).
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of depression
Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 8a (8-40; where lower scores indicate less depression).
Measured: 6 weeks
Minimal clinically important difference (MCID) in cognitive function
Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 4a (4-20; where lower scores indicate poorer cognitive function).
Measured: 6 weeks
Minimal clinically important difference (MCID) in cognitive function
Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 8a (8-40; where lower scores indicate poorer cognitive function).
Measured: 6 weeks
Minimal clinically important difference (MCID) in sleep disturbance
Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 4a (4-20; where lower scores indicate less sleep disturbance).
Measured: 6 weeks
Minimal clinically important difference (MCID) in sleep disturbance
Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 8a (8-40; where lower scores indicate less sleep disturbance).
Measured: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 4a (4-20; where lower scores indicate less fatigue).
Measured: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8a (8-40; where lower scores indicate less fatigue).
Measured: 6 weeks
Minimal clinically important difference (MCID) in pain interference
Likelihood of achieving a MCID in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference).
Measured: 6 weeks
Minimal clinically important difference (MCID) in pain intensity
Likelihood of achieving a MCID in pain intensity, as measured by PROMIS Pain intensity (3-15; where lower scores indicate less pain intensity).
Measured: 6 weeks
Minimal clinically important difference (MCID) in interest in sexual function
Likelihood of achieving a MCID in interest in sexual activity, as measured by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749288
- Sponsor's protocol ID
- RADX-P-2414
- Status last verified
- Jul 2025
- First submitted
- 19 Dec 2024
- Last updated
- 4 Jul 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06749288
- Acronym / sponsor ID
- RADX-P-2414
- Conditions
- Menopause, Sleep Disturbance, Anxiety, Depression, Cognitive Function, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 27 Dec 2024 (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 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 menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, 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 women 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 4.1.0 | Placebo comparator | Dietary Supplement: Radicle Revive Placebo Control Form 4.1Revive product form 4.1 - control |
| Active product 4.1.1 | Experimental | Dietary Supplement: Radicle Revive Active Study Product 4.1 UsageRevive product form 4.1 - active product 1 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 4.1Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo control 4.1.0 |
| Radicle Revive Active Study Product 4.1 UsageParticipants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks. | Dietary supplement | Active product 4.1.1 |
Primary outcome
Change in feelings of anxiety
Time frame: 6 weeks
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Change in feelings of anxiety
Time frame: 6 weeks
Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Change in feelings of depression
Time frame: 6 weeks
Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)
Change in cognitive function
Time frame: 6 weeks
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)
Change in cognitive function
Time frame: 6 weeks
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)
Change in sleep disturbance
Time frame: 6 weeks
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)
Change in sleep disturbance
Time frame: 6 weeks
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; with higher scores corresponding to more severe sleep disturbance)
Change in fatigue
Time frame: 6 weeks
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)
Change in feelings of depression
Time frame: 6 weeks
Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)
Change in fatigue
Time frame: 6 weeks
Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)
Change in Pain Interference
Time frame: 6 weeks
Mean difference in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)
Change in pain intensity
Time frame: 6 weeks
Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Change in interest in sexual activity
Time frame: 6 weeks
Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)
14 secondary outcomes
Change in other menopausal health issues
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of depression
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of depression
Time frame: 6 weeks
Minimal clinically important difference (MCID) in cognitive function
Time frame: 6 weeks
Minimal clinically important difference (MCID) in cognitive function
Time frame: 6 weeks
Minimal clinically important difference (MCID) in sleep disturbance
Time frame: 6 weeks
Minimal clinically important difference (MCID) in sleep disturbance
Time frame: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Time frame: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Time frame: 6 weeks
Minimal clinically important difference (MCID) in pain interference
Time frame: 6 weeks
Minimal clinically important difference (MCID) in pain intensity
Time frame: 6 weeks
Minimal clinically important difference (MCID) in interest in sexual function
Time frame: 6 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 4 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4.1 Usage in people with Menopause and Sleep Disturbance, 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 5 inclusion and 10 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 4 Jul 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 feelings of anxiety (time frame: 6 weeks). The study lists 13 primary outcomes in all. 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 4 Jul 2025.