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OpenTrials
Completed

NCT Number: NCT06124300

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

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Key information

Conditions

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

Age range

18 year–55 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: Yes

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

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

Treatment and study plan

Female Hormone Balance Supplement

Dietary Supplement

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

Primary outcomes

  1. 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").

  2. 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").

  3. 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").

Secondary outcomes

  1. 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").

  2. 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").

  3. 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").

  4. 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").

  5. 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").

Sponsors and collaborators

Lead sponsor

Rael

Industry

Collaborators

  • Citruslabs

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
Aug 23, 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.

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