Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590337
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Radicle Spark for Men 24 a Study of Health and Wellness Products on Sexual Health and Related Health Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radicle Spark for Men 24 a Randomized Double-Blind Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sexual Health and Related Health Outcomes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double-blind placebo-controlled study assessing the impact of health and wellness products on sexual health and related health outcomes
Detailed Description:
This is a randomized double-blind placebo-controlled study conducted with adult participants residing in the United States
Eligible participants will 1 endorse a desire for improved libido sexual satisfaction andor function 2 have the opportunity for meaningful improvement at least 30 in their primary health outcome and 3 express acceptance in taking a product and not knowing its formulation 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 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 will 1 endorse a desire for improved libido sexual satisfaction andor function 2 have the opportunity for meaningful improvement at least 30 in their primary health outcome and 3 express acceptance in taking a product and not knowing its formulation 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 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None