A Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

May 15, 2023 updated by: 906 CMVI Holdings

A Single-Group, Open-Label Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male (biological at birth) within the LGBTQIA+ community
  • Aged between 18-44
  • Generally healthy - don't live with any uncontrolled chronic disease
  • Generally active lifestyle or seeking to achieve health improvement
  • Sexually active with a partner

Exclusion Criteria:

  • Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Anyone with known severe allergic reactions.
  • Unwilling to follow the study protocol.
  • Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g. eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder)
  • Current substance abuse disorder
  • Diagnosis of an autoimmune disease, such as multiple sclerosis and rheumatoid arthritis
  • Self-reported or diagnosed high blood pressure or hypotension (BP < 90 over 60)
  • Currently, or in the past 6 months, undergoing hormone therapy
  • Any medical condition that is unstable or uncontrolled
  • A history of sexual trauma or abuse
  • Has introduced any new prescription medication or supplements within the past 12 weeks that influence gastrointestinal issues, libido, or testosterone production.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

Participants will begin taking the Reset supplement for 5 days. Then there will be a 2-day break with no products taken (wash out period).

Participants will then begin taking the following 2 supplements: Stay Ready Fiber and libido with a partial overlap of products.

Stay Ready Fiber will be taken from day 7 through 21, three capsules will be taken twice daily in the morning and afternoon.

Libido will be taken from day 7 through 28, 2 capsules will be taken daily, preferably with a meal.

Participants will then begin taking the Testosterone supplement. Testosterone will be taken from day 28 through to 84, 2 capsules will be taken daily, preferably with a meal.
Dietary supplement: Reset
Pure for Men Reset is a Vegan, Proprietary Blend of Toxin Eliminating Cleanser: Cascara Sagrada Bark, Senna Leaf, Psyllium Husk, Licorice Root, and Aloe Vera Gel. Taken on Day 1 to Day 5.
Other Names:
  • Pure for Men Reset Supplement
Dietary supplement: Stay Ready Fiber
Stay Ready Fiber is a Vegan, 100% Natural, Proprietary Blend of Digestive Aids: Psyllium Husk, Aloe Vera Extract, Chia Seeds & Flaxseed. Taken from Day 7 through Day 21.
Other Names:
  • Pure for Men Stay Ready Fiber Capsules
Dietary supplement: Libido
Supplement designed to support endurance and increased arousal. Contains L-Citrulline, L-Arginine and Black Pepper Fruit Extract (Piper Nigrum). Taken from Day 7 through to Day 28.
Other Names:
  • Pure for Men Pump Enhancer
Dietary supplement: Testosterone supplement
Supplement designed to enhance testosterone production. Contains Ashwagandha, Zinc, Vitamin D, Maca, and Tongkat Ali. Taken from Day 28 through Day 84.
Other Names:
  • Pure for Men T-Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in subject's perception of readiness and confidence for intimacy, and sex drive/arousal [Time Frame: Baseline to 12 weeks]
Time Frame: 12 weeks
Survey-based assessment (0-5 scale) of changes in reduction in preparation time for intimacy, sexual arousal, and sexual endurance.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life [Time Frame: Baseline to 12 weeks]
Time Frame: 12 weeks
Survey-based assessment (0-5 scale) of changes in digestion, stamina and endurance during workouts, overall confidence, mood and quality of life.
12 weeks

Collaborators and Investigators

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

Sponsor

906 CMVI Holdings

Collaborators

Citruslabs

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 (Actual)

March 14, 2023

Primary Completion (Anticipated)

June 6, 2023

Study Completion (Anticipated)

June 13, 2023

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20287

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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