Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms

NCT07018479 | Completed

• 1 other identifier: 20453
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenstrual Syndrome

Keywords

PMS; hormonal supplement; female hormone balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant Perception of Supplement Effectiveness

  Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

Study Arms (1)

FemmeBalance Supplement Group

EXPERIMENTAL

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

Interventions

FemmeBalance Supplement Group DIETARY_SUPPLEMENT

Participants will take two capsules daily of the FemmeBalance supplement with their evening meal for four menstrual cycles

FemmeBalance Supplement Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VINABAS FORMULATIONS SL: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 30, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)