Hormone RegulationNCT06531668
A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
A study testing Beyond Hormone in people with Hormone Regulation, run by Scale Media Inc at 1 site in United States.
Trial summary
This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Hormone Regulation
- What is being tested?
- Beyond Hormone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 7 Sep 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female at-birth, aged 25-45.
- Not menopausal or perimenopausal.
- Regularly menstruating.
- Not taking any medication, supplement, or vitamin affecting hormone levels.
- Generally healthy and not living with any uncontrolled chronic disease.
Who cannot join
- Medical conditions or treatments affecting hormonal regulation.
- Endocrine disorders, gynecological or reproductive health conditions.
- Use of hormonal contraceptives or hormone therapy.
- Recent major illness or surgery.
- Severe allergies or hypersensitivities.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.
- Conditions
- Hormone Regulation
- Being tested
- Beyond Hormone, Placebo
- Keywords
- Women's Health, Menstrual Cycle, Estrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beyond HormoneDietary supplement
Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.
PlaceboOther
Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Beyond Hormone Supplement | Experimental | Participants in this arm will receive the Beyond Hormone supplement. Receives: Dietary Supplement: Beyond Hormone |
| Placebo | Placebo comparator | Participants in this arm will receive a placebo consisting of rice flour encapsulated in a vegetable cellulose capsule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)
Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Measured: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Secondary outcomes (4)
Participants' Perceptions of Quality of Life
Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire.
Measured: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)
Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Measured: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)
Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Measured: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Libido using a Libido Questionnaire
Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
Measured: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start7 Jun 2024
- Primary completion7 Sep 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone RegulationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scale Media Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531668
- Sponsor's protocol ID
- 20431
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
- ClinicalTrials.gov ID
- NCT06531668
- Acronym / sponsor ID
- 20431
- Conditions
- Hormone Regulation
- Keywords
- Women's Health, Menstrual Cycle, Estrogen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Scale Media IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 7 Sep 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 1 Aug 2024 (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 randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beyond Hormone Supplement | Experimental | Dietary Supplement: Beyond HormoneParticipants in this arm will receive the Beyond Hormone supplement. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a placebo consisting of rice flour encapsulated in a vegetable cellulose capsule. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female at-birth, aged 25-45.
- Not menopausal or perimenopausal.
- Regularly menstruating.
- Not taking any medication, supplement, or vitamin affecting hormone levels.
- Generally healthy and not living with any uncontrolled chronic disease.
Key exclusion criteria (5 listed)
- Medical conditions or treatments affecting hormonal regulation.
- Endocrine disorders, gynecological or reproductive health conditions.
- Use of hormonal contraceptives or hormone therapy.
- Recent major illness or surgery.
- Severe allergies or hypersensitivities.
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 |
|---|---|---|
| Beyond HormoneParticipants will take three capsules once daily with their morning meal for the duration of three menstrual cycles. | Dietary supplement | Beyond Hormone Supplement |
| PlaceboParticipants will take three capsules once daily with their morning meal for the duration of three menstrual cycles. | Other | Placebo |
Primary outcome
Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)
Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).
4 secondary outcomes
Participants' Perceptions of Quality of Life
Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)
Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)
Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Participants' Libido using a Libido Questionnaire
Time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- 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 Beyond Hormone in people with Hormone Regulation, run by Scale Media Inc 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone) (time frame: Baseline (Day 0), Midline (Day 45), and Endline (Day 90)). 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 1 Aug 2024.