Polycystic Ovary SyndromeNCT06124300
Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
A study testing Female Hormone Balance Supplement in people with Polycystic Ovary Syndrome and Premenstrual Syndrome, run by Rael at 1 site in United States.
Trial summary
This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Premenstrual Syndrome
- What is being tested?
- Female Hormone Balance Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 19 Jan 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 18 - 55
- BMI less than 35
- Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- Generally healthy - don't live with any uncontrolled chronic disease
- Self-reported symptoms of PCOS - irregular periods
- Self-reported concerns with hormonal skin issues
Who cannot join
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with known severe allergic reactions
- Anyone who is pregnant, breastfeeding, or attempting to become pregnant
- Unwilling to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks
- Conditions
- Polycystic Ovary Syndrome, Premenstrual Syndrome
- Being tested
- Female Hormone Balance Supplement
- Medical subject headings
- Polycystic Ovary Syndrome, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Female Hormone Balance SupplementDietary supplement
The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12
| Study group | Role | What they receive |
|---|---|---|
| Female Hormone Balance Supplement | Experimental | Participants will add 1 scoop of the powder to a drink of choice every morning. Receives: Dietary Supplement: Female Hormone Balance Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in menstrual cycle regularity.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Very regular") and 1 representing the least favorable/worst outcome (e.g., "Extremely irregular").
Measured: Baseline to Week 12
Changes in hormonal acne.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Changes in skin issues throughout the menstrual cycle.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Secondary outcomes (5)
Changes in overall mood.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Changes in stress levels.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Changes in food cravings.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Changes in energy.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Changes in menstrual cramps.
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 Aug 2023
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rael
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124300
- Sponsor's protocol ID
- 20336
- Status last verified
- Aug 2024
- First submitted
- 4 Nov 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06124300
- Acronym / sponsor ID
- 20336
- Conditions
- Polycystic Ovary Syndrome, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RaelIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 9 Nov 2023 (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 is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female Hormone Balance Supplement | Experimental | Dietary Supplement: Female Hormone Balance SupplementParticipants will add 1 scoop of the powder to a drink of choice every morning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged between 18 - 55
- BMI less than 35
- Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- Generally healthy - don't live with any uncontrolled chronic disease
- Self-reported symptoms of PCOS - irregular periods
Key exclusion criteria (4 listed)
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with known severe allergic reactions
- Anyone who is pregnant, breastfeeding, or attempting to become pregnant
- Unwilling to follow the study protocol
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 |
|---|---|---|
| Female Hormone Balance SupplementThe product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12 | Dietary supplement | Female Hormone Balance Supplement |
Primary outcome
Changes in menstrual cycle regularity.
Time frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Very regular") and 1 representing the least favorable/worst outcome (e.g., "Extremely irregular").
Changes in hormonal acne.
Time frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in skin issues throughout the menstrual cycle.
Time frame: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
5 secondary outcomes
Changes in overall mood.
Time frame: Baseline to Week 12
Changes in stress levels.
Time frame: Baseline to Week 12
Changes in food cravings.
Time frame: Baseline to Week 12
Changes in energy.
Time frame: Baseline to Week 12
Changes in menstrual cramps.
Time frame: Baseline to Week 12
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 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 Female Hormone Balance Supplement in people with Polycystic Ovary Syndrome and Premenstrual Syndrome, run by Rael 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 6 inclusion and 4 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 23 Aug 2024. 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?
Changes in menstrual cycle regularity. (time frame: Baseline to Week 12). The study lists 3 primary outcomes in all. 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 23 Aug 2024.