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

Study Overview
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Brief Summary
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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

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

Conditions
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Polycystic Ovary Syndrome, Premenstrual Syndrome

Intervention / Treatment
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* Dietary Supplement: Female Hormone Balance Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female Hormone Balance Supplement<br>Participants will add 1 scoop of the powder to a drink of choice every morning. | Dietary Supplement: Female Hormone Balance Supplement<br>* The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in menstrual cycle regularity. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |