Premenstrual SyndromeNCT07018479
Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
A study testing FemmeBalance Supplement Group in people with Premenstrual Syndrome, run by VINABAS FORMULATIONS SL at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- FemmeBalance Supplement Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- FemmeBalance Supplement Group
- Keywords
- PMS, hormonal supplement, female hormone balance
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemmeBalance Supplement GroupDietary supplement
Participants will take two capsules daily of the FemmeBalance supplement with their evening meal for four menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| FemmeBalance Supplement Group | Experimental | Two capsules daily of FemmeBalance, containing Sabal Serrulata, NAC, turmeric extract, chasteberry extract, vitamin B5, black pepper extract, and excipients. Receives: Dietary Supplement: FemmeBalance Supplement Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Secondary outcomes (1)
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.
Measured: Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Jul 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VINABAS FORMULATIONS SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018479
- Sponsor's protocol ID
- 20453
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
- ClinicalTrials.gov ID
- NCT07018479
- Acronym / sponsor ID
- 20453
- Conditions
- Premenstrual Syndrome
- Keywords
- PMS, hormonal supplement, female hormone balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VINABAS FORMULATIONS SLIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FemmeBalance Supplement Group | Experimental | Dietary Supplement: FemmeBalance Supplement GroupTwo capsules daily of FemmeBalance, containing Sabal Serrulata, NAC, turmeric extract, chasteberry extract, vitamin B5, black pepper extract, and excipients. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemmeBalance Supplement GroupParticipants will take two capsules daily of the FemmeBalance supplement with their evening meal for four menstrual cycles | Dietary supplement | FemmeBalance Supplement Group |
Primary outcome
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).
1 secondary outcome
Participant Perception of Supplement Effectiveness
Time frame: Day 7 of each menstrual cycle over 4 cycles (~16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemmeBalance Supplement Group in people with Premenstrual Syndrome, run by VINABAS FORMULATIONS SL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PMS Symptoms (time frame: Baseline and Day 7 of each menstrual cycle over 4 cycles (~16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.