A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women

Not Applicable

Active, not recruiting

• Conditions: Hormone Regulation

• Registration Number: NCT06531668
• Lead Sponsor: Scale Media Inc

Brief Summary

This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-09-07
• Study Completion: 2024-09-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Female at-birth, aged 25-45.
• Not menopausal or perimenopausal.
• Regularly menstruating.
• Not taking any medication, supplement, or vitamin affecting hormone levels.
• Generally healthy and not living with any uncontrolled chronic disease.

Exclusion Criteria

• Medical conditions or treatments affecting hormonal regulation.
• Endocrine disorders, gynecological or reproductive health conditions.
• Use of hormonal contraceptives or hormone therapy.
• Recent major illness or surgery.
• Severe allergies or hypersensitivities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)	Baseline (Day 0), Midline (Day 45), and Endline (Day 90)	Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).

Secondary Outcome Measures

Name	Time	Method
Participants' Perceptions of Quality of Life	Baseline (Day 0), Midline (Day 45), and Endline (Day 90)	Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire.
Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)	Baseline (Day 0), Midline (Day 45), and Endline (Day 90)	Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)	Baseline (Day 0), Midline (Day 45), and Endline (Day 90)	Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Participants' Libido using a Libido Questionnaire	Baseline (Day 0), Midline (Day 45), and Endline (Day 90)	Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States