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

NCT06531668 | Active Not Recruiting

• 1 other identifier: 20431
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Regulation

Keywords

Women's Health; Menstrual Cycle; Estrogen

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Secondary Outcomes (4)

• Participants' Perceptions of Quality of Life

  Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

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

  Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

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

  Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

• Participants' Libido using a Libido Questionnaire

  Baseline (Day 0), Midline (Day 45), and Endline (Day 90)

Study Arms (2)

Beyond Hormone Supplement

EXPERIMENTAL

Participants in this arm will receive the Beyond Hormone supplement.

Dietary Supplement: Beyond Hormone

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive a placebo consisting of rice flour encapsulated in a vegetable cellulose capsule.

Other: Placebo

Interventions

Beyond Hormone DIETARY_SUPPLEMENT

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

Beyond Hormone Supplement

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scale Media Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 1, 2024
• Study Start: June 7, 2024
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)