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

N/AActive Not RecruitingNCT06531668

Scale Media Inc50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hormone Regulation

Interventions

Beyond HormoneDIETARY_SUPPLEMENT

Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.

PlaceboOTHER

Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)

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).

Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Secondary Outcomes

Participants' Perceptions of Quality of Life

Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire.

Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)

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).

Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)

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).

Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Participants' Libido using a Libido Questionnaire

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).

Data from ClinicalTrials.gov

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