Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome

August 21, 2024 updated by: Rael

A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome

This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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:

  • Women aged between 18 - 55
  • BMI less than 35
  • Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
  • Generally healthy - don't live with any uncontrolled chronic disease
  • Self-reported symptoms of PCOS - irregular periods
  • Self-reported concerns with hormonal skin issues

Exclusion Criteria:

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Anyone with known severe allergic reactions
  • Anyone who is pregnant, breastfeeding, or attempting to become pregnant
  • Unwilling to follow the study protocol

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: Female Hormone Balance Supplement
Participants will add 1 scoop of the powder to a drink of choice every morning.
Dietary supplement: Female Hormone Balance Supplement
The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in menstrual cycle regularity.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Very regular") and 1 representing the least favorable/worst outcome (e.g., "Extremely irregular").
Baseline to Week 12
Changes in hormonal acne.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12
Changes in skin issues throughout the menstrual cycle.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in overall mood.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12
Changes in stress levels.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12
Changes in food cravings.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12
Changes in energy.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12
Changes in menstrual cramps.
Time Frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Baseline to Week 12

Collaborators and Investigators

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

Sponsor

Rael

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)

August 30, 2023

Primary Completion (Actual)

January 19, 2024

Study Completion (Actual)

January 19, 2024

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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