Radicle Science's menopause fatigue trial moves to Active, not recruiting
The 550-participant, placebo-controlled study of a wellness-product regimen for menopausal fatigue closed enrollment on schedule, setting up a May 2027 primary readout.
Executive Summary
- Radicle Science's menopausal-fatigue study moved to Active, not recruiting after closing enrollment at its planned size, a routine transition for a trial that has finished recruiting.
- The randomized, placebo-controlled, double-masked study asks whether a wellness-product regimen changes fatigue and related quality-of-life measures in women with menopausal symptoms over a defined follow-up window.
- The menopausal-symptoms field is populated by hormonal therapies and botanical supplements already in Phase 3 or Phase 4 testing, none sharing this trial's product class, leaving no same-mechanism precedent to benchmark the outcome against.
- The primary readout on change in fatigue is due around the trial's completion date, and that data, not this status update, will be the first evidence of whether the regimen moves the needle.
The status change
Radicle Science's trial, titled Radicle Women's Health, moved from Not yet recruiting to Active, not recruiting on July 16, 2026. The trial started on May 7, 2026, and the status update reflects that enrollment reached its target of 550 adult women ages 35 to 60 with at least two menopausal symptoms. The primary completion date is listed as May 11, 2027. NCT07572578+1Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal SymptomsNCT07572578Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal SymptomsJul 16, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The design
The study is a randomized, double-masked, placebo-controlled trial with two arms testing a wellness-product regimen against placebo. Its primary endpoint measures the difference in rate of change in fatigue over 7 weeks, using the PROMIS Fatigue 8A scale, an 8-to-40-point patient-reported measure where higher scores indicate more severe fatigue. Secondary endpoints track cognitive function, anxiety, and menopause-specific quality of life over the same window, with additional analyses of whether participants reach a minimal clinically important difference on each measure. The trial is not registrational. NCT07572578Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal SymptomsNCT07572578
Enrollment held at target
The enrollment figure did not move between the trial's first registration and this status update: both list 550 participants, a 0% change that falls well inside the routine range for a study transitioning out of active recruitment. No protocol amendments touched the primary endpoint, eligibility criteria, or completion date between the trial's initial posting and this update, and the registry shows only the single status change alongside the initial filing. NCT07572578Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal SymptomsNCT07572578
The competitive field
No same-drug or same-mechanism precedent exists for this wellness-product regimen in menopausal symptoms; the closest comparators on record are indication-level, not mechanism-level. Estradiol from Wyeth (now part of Pfizer), Bayer's drospirenone, and Organon's tibolone are hormonal therapies in Phase 4 testing for menopausal symptoms, while Schaper & Bruemmer's black cohosh and A. Vogel's Sage Tablets represent botanical entrants also studied in Phase 3 and Phase 4 trials. None of these share this trial's product class or mechanism, so the field offers no direct benchmark for what a positive result here would need to show; the informative bar is whether the regimen separates from placebo on fatigue by a margin that also clears the study's own minimal-clinically-important-difference threshold.
Sponsor track record
Radicle Science has completed 14 of its prior trials with no terminations on record, and currently runs 30 trials across various stages, including 8 recruiting and 6 active-not-recruiting. That completion history supports the operational read that this enrollment-complete transition is proceeding as expected rather than signaling distress.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.