NCT04245527

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 25, 2020

Last Update Submit

January 28, 2020

Conditions

Testosterone DeficiencyEstrogen Deficiency

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Study Arm

EXPERIMENTAL

20 minutes Joovv Solo every day for 8 weeks.

Device: Joovv Infrared Light Device

Interventions

Joovv Infrared Light DeviceDEVICE

Joovv is the leading manufacturer of personal, in-home red light therapy devices

Study Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • United States resident

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProofPilot (Virtual Study: https://p.proofpilot.com)

New York, New York, 10003, United States

Location

Central Study Contacts

Matthew M Amsden

CONTACT

3232844626crew@proofpilot.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Enrolled individuals will receive a Joovv solo for the 8 week study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2020

First Posted

January 29, 2020

Study Start

January 31, 2020

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)