HealthyNCT07033013
A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC at 1 site in United States.
Trial summary
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Supplement with actives
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Females aged 40 to 65 years
- Self-reporting menopausal symptoms (> 5 hot flashes per day) and have been present for a minimum of previous 60 days prior to baseline visit
- Reporting a variable cycle length of > 7 days different from normal
- NORMAL BMI (per metropolitan life tables): under 30 kg/m2
- Able to read, understand, and complete the study questionnaire and records.
- Able to understand the study procedures.
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- Able to comply with all study requirements.
- Written informed consent to participate in the study.
- Willingness to actively participate in the study and to come to the scheduled visits.
Who cannot join
- Pregnancy or breastfeeding.
- Immune insufficiency
- Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
- History of hysterectomy
- Women on hormone replacement therapy
- Use of systemic corticosteroids or immunosuppressant drugs.
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- Other diseases or medications that might directly interfere in the study or put the panelist's health under risk, such as: thyroid disease, diabetes mellitus, history of hormone dependent (gynecological) cancer, endometrial hyperplasia, uterine cancer, endometrial cancer, drug and alcohol abuse, mental disorder, abnormality in renal and liver functions, personal or family history of breast cancer in a first degree relative, and history of clotting disorder such as deep vein thrombosis.)
- Cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol
- Alcohol or drug abuse
- Use of hormonal contraceptives within the last 3 months
- Use of other menopause supplements or drugs
- Uncontrolled hypertension (160/100 mmHg or higher, measured after 10 min of seated rest)
- Oophorectomy or amenorrhea > two years.
- Participating in a different clinical trial within one month of the start of this clinical trial or planning to participate in another clinical trial during the trial period
- Continuous intake of foods based on Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai within the past month
- Employees of the institute or the brand owner or the manufacturers of the product
- Note: Habitual medicine and supplement intake will be registered prior to inclusion in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
John Ademola, jademola@sfinstitute.com
About this study
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement
- Conditions
- Healthy
- Being tested
- Placebo, Dietary Supplement with actives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Dietary Supplement with activesDietary supplement
Dietary supplement containing EstroG-100 and GABA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. Receives: Dietary Supplement: Placebo |
| Dietary Supplement with actives | Active comparator | Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. Receives: Dietary Supplement: Dietary Supplement with actives |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour effects following single dose of Mellow Menopause - Hot Flashes
To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary.
Measured: From baseline Day 7 to Treatement Day 1 (Day 8 of study)
Secondary outcomes (1)
Improvement of overall daily menopausal vasomotor symptoms
To assess the efficacy for improvement of overall daily menopausal vasomotor symptoms compared to placebo through daily diary data and MenoLife diary though 7 days. Data in the Daily diary and MenoLife Diary will be compared between the active supplement and placebo groups across different time points.
Measured: from enrollment to end of study at Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start7 Jul 2025
- Primary completion25 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olly, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033013
- Sponsor's protocol ID
- UNLV20250320
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).
- ClinicalTrials.gov ID
- NCT07033013
- Acronym / sponsor ID
- UNLV20250320
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 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.
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInstructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with activesInstructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy Females aged 40 to 65 years
- Self-reporting menopausal symptoms (> 5 hot flashes per day) and have been present for a minimum of previous 60 days prior to baseline visit
- Reporting a variable cycle length of > 7 days different from normal
- NORMAL BMI (per metropolitan life tables): under 30 kg/m2
- Able to read, understand, and complete the study questionnaire and records.
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding.
- Immune insufficiency
- Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
- History of hysterectomy
- Women on hormone replacement therapy
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 |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | Placebo |
| Dietary Supplement with activesDietary supplement containing EstroG-100 and GABA | Dietary supplement | Dietary Supplement with actives |
Primary outcome
24 hour effects following single dose of Mellow Menopause - Hot Flashes
Time frame: From baseline Day 7 to Treatement Day 1 (Day 8 of study)
To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary.
1 secondary outcome
Improvement of overall daily menopausal vasomotor symptoms
Time frame: from enrollment to end of study at Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC 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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 16 Jul 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour effects following single dose of Mellow Menopause - Hot Flashes (time frame: From baseline Day 7 to Treatement Day 1 (Day 8 of study)). 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 16 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.