Use of Infrared Photomodulation for Hormonal Balance (Joo... | NCT04245527

Studies
Use of Infrared Photomodulation for Hormonal Balance (Joovvin' for Hormonal Health)

NCT04245527

Sponsor

ProofPilot

Status

Unknown status

Last Update Posted

Jan 30, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Testosterone Deficiency
Estrogen Deficiency

Interventions

Joovv Infrared Light Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2020Estimated

Primary Completion Date

May 1, 2020Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Jan 25, 2020

First Submission Date that Met QC Criteria

Jan 25, 2020

First Posted Date

Jan 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2020

Last Update Posted Date

Jan 30, 2020Actual

Name	Class
Joovv	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Arm	Experimental	20 minutes Joovv Solo every day for 8 weeks.	Device: Joovv Infrared Light Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Joovv Infrared Light Device	Device	Joovv is the leading manufacturer of personal, in-home red light therapy devices	Study Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Testosterone Change	in males, change from baseline to week 8	baseline to week 8
change of thyroid-stimulating hormone (TSH)	in females change in estrogen and progesterone from baseline to week 8	baseline to week 8
Self report general wellness	series of questions at baseline and week 8 on general wellness (modified Short Form-36)	baseline to week 8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

United States resident

Exclusion Criteria:

current Joovv or other photomodulation therapy user
under medical supervision for medically treatable illness
significant travel during study period
use of birth control

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew M Amsden	Contact	3232844626		crew@proofpilot.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ProofPilot (Virtual Study: https://p.proofpilot.com)		New York	New York	10003	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

there is no current plan to make IPD available to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided