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

NCT06124300 | Completed

• 1 other identifier: 20336
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome; Premenstrual Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Changes in overall mood.

  Baseline to Week 12

• Changes in stress levels.

  Baseline to Week 12

• Changes in food cravings.

  Baseline to Week 12

• Changes in energy.

  Baseline to Week 12

• Changes in menstrual cramps.

  Baseline to Week 12

Study Arms (1)

Female Hormone Balance Supplement

EXPERIMENTAL

Participants will add 1 scoop of the powder to a drink of choice every morning.

Dietary Supplement: Female Hormone Balance Supplement

Interventions

Female Hormone Balance Supplement DIETARY_SUPPLEMENT

The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12

Female Hormone Balance Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rael: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: August 30, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)