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Active, Not Recruiting

NCT Number: NCT06531668

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hormone Regulation

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beyond Hormone

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Participants' Perceptions of Quality of Life

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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).

  4. Participants' Libido using a Libido Questionnaire

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Scale Media Inc

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.