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Completed

NCT Number: NCT07018479

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

FemmeBalance Supplement Group

Dietary Supplement

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

Primary outcomes

  1. Change in PMS Symptoms

    Time frame: Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)

    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).

Secondary outcomes

  1. Participant Perception of Supplement Effectiveness

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

    Self-reported participant feedback on perceived effectiveness of the supplement, collected through questionnaires. These responses are qualitative and not subject to statistical analysis.

Sponsors and collaborators

Lead sponsor

VINABAS FORMULATIONS SL

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

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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