MenopauseNCT05617287
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
A study testing Semaine Menopause Supplement in people with Menopause and Menopause Related Conditions, run by Semaine Health at 1 site in United States.
Trial summary
A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention. Read more about this study
- Who is it for?
- Ages 40 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopause Related Conditions, Perimenopausal Disorder
- What is being tested?
- Semaine Menopause Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2022to 1 Jan 2023
- 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 40 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
- Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.
Who cannot join
- Current use of medication for high blood pressure or for blood thinning
- Currently undergoing chemotherapy or has previously been treated for cancer
- Pregnancy, breastfeeding, or attempting to become pregnant during the study
- Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )
Trial locations and contacts
1 site in 1 country.
About this study
A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.
- Being tested
- Semaine Menopause Supplement
- Keywords
- Menopause, Perimenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaine Menopause SupplementDietary supplement
Synergistic Dietary Supplement
| Study group | Role | What they receive |
|---|---|---|
| Semaine Supplement | Experimental | Participants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.) Receives: Dietary Supplement: Semaine Menopause Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido.
This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start3 Sep 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semaine Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Christopher Hill, Principal investigator, CitruslabsMatthew Crane, Principal investigator, Semaine Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617287
- Sponsor's protocol ID
- 20265
- Status last verified
- Apr 2023
- First submitted
- 7 Nov 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
- ClinicalTrials.gov ID
- NCT05617287
- Acronym / sponsor ID
- 20265
- Keywords
- Menopause, Perimenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Semaine HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Nov 2022 (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.
A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaine Supplement | Experimental | Dietary Supplement: Semaine Menopause SupplementParticipants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.) |
Who may qualify
- Ages
- 40 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
- Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.
Key exclusion criteria (4 listed)
- Current use of medication for high blood pressure or for blood thinning
- Currently undergoing chemotherapy or has previously been treated for cancer
- Pregnancy, breastfeeding, or attempting to become pregnant during the study
- Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )
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 |
|---|---|---|
| Semaine Menopause SupplementSynergistic Dietary Supplement | Dietary supplement | Semaine Supplement |
Primary outcome
Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
Time frame: 12 weeks
Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido. This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7.
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 13 Apr 2023.
- 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.
Christopher Hill principal investigator
Citruslabs
Matthew Crane principal investigator
Semaine Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaine Menopause Supplement in people with Menopause and Menopause Related Conditions, run by Semaine Health 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 2 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 13 Apr 2023. 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 perceived discomfort associated with the most common symptoms linked with perimenopause and menopause (time frame: 12 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 13 Apr 2023.