Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT07117994
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues
Sponsor:
Radicle Science
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: