Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms

This virtual single-group study evaluates the effects of the FemmeBalance supplement on symptoms of premenstrual syndrome (PMS) over four menstrual cycles. The study involves daily intake of the supplement, regular questionnaires, and skin photo submissions for dermatological grading.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Dietary supplement: FemmeBalance Supplement Group

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female, aged 18-40.
• Self-reported symptoms of PMS for at least three consecutive months, including but not limited to pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness.
• Generally healthy and not living with any uncontrolled chronic disease.
• Has a regular menstrual cycle between 21 and 35 days in length.
• Willing to maintain the same diet, sleep schedule, and activity level for the duration of the study (at least 16 weeks).
• Own a smartphone with a camera.
• Must reside in the United States.

Exclusion Criteria:

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
• Anyone with known severe allergic reactions that require the use of an Epi-pen or any allergies to any of the product ingredients.
• Women who are pregnant, breastfeeding, or trying to conceive.
• Anyone who is unwilling or unable to follow the study protocol.
• Anyone previously diagnosed with premenstrual dysphoric disorder (PMDD), endometriosis, or any cancer of the reproductive system.
• Anyone who is peri- or post-menopausal.
• Anyone who is currently on hormonal birth control or who has been on hormonal birth control in the last three months.
• Anyone who is taking any products, medication, or supplements that target the symptoms of PMS.
• Anyone who has undergone any surgeries or invasive treatments in the last six months or who is planning on undergoing any in the study duration.
• Anyone who has had any major illness in the last three months.
• Anyone who is currently undergoing, or who plans to undergo in the study period, any procedures relating to reproductive health and/or the menstrual cycle, e.g., a hysterectomy, ovary removal, or similar procedure.
• Anyone who suffers from amenorrhoea or irregular periods (<21 days or >35 days apart on average).
• Anyone who is currently participating in or who plans to participate in another trial during the study period.
• Anyone with a history of substance abuse.
• Anyone who smokes or who has been a smoker in the past three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FemmeBalance Supplement Group; Two capsules daily of FemmeBalance, containing Sabal Serrulata, NAC, turmeric extract, chasteberry extract, vitamin B5, black pepper extract, and excipients.	Dietary supplement: FemmeBalance Supplement Group; Participants will take two capsules daily of the FemmeBalance supplement with their evening meal for four menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PMS Symptoms	Change in self-reported symptoms of premenstrual syndrome, including pelvic pain, mood swings, acne, hair loss, fluid retention, breast pain/tenderness, irritability, and episodes of crying or sadness, assessed using validated questionnaires (PSST and study-specific tools).	Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Perception of Supplement Effectiveness	Self-reported participant feedback on perceived effectiveness of the supplement, collected through questionnaires. These responses are qualitative and not subject to statistical analysis.	Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

Collaborators and Investigators

• Sponsor: VINABAS FORMULATIONS SL
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: June 4, 2025
• First Submitted That Met QC Criteria: June 4, 2025
• First Posted (Actual): June 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: PMS; hormonal supplement; female hormone balance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: 20453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No