Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

What this trial studies

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

Conditions in scope

• Menopause
• Sleep Disturbance
• Anxiety
• Depression
• Cognitive Function
• Fatigue
• Libido

Interventions

• Radicle Revive Placebo Control Form 4.1 (Dietary Supplement) — Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
• Radicle Revive Active Study Product 4.1 Usage (Dietary Supplement) — Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

Who can join

Women only · Ages 21 Years to 105 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2025-01-01
• Primary completion: 2025-07-01
• Last update posted: 2025-07-04
• First posted: 2024-12-27

Sponsor & contact

Lead sponsor: Radicle Science (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in feelings of anxiety (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 (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 (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 (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 (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)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.