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

January 28, 2020 updated by: ProofPilot

Joovvin' for Hormonal Health

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • ProofPilot (Virtual Study: https://p.proofpilot.com)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
20 minutes Joovv Solo every day for 8 weeks.
Device: Joovv Infrared Light Device
Joovv is the leading manufacturer of personal, in-home red light therapy devices

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProofPilot

Collaborators

Joovv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 31, 2020

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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