Clinical trial NCT07018479: Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
Official title: Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: PMS
hormonal supplement
female hormone balance
Lead sponsor: VINABAS FORMULATIONS SL
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2025-06-12
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in PMS Symptoms
timeFrame: Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Secondary outcomes:
measure: Participant Perception of Supplement Effectiveness
timeFrame: Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Citruslabs
state: Nevada
Study officials:
References: