Menopausal SymptomsNCT06787443
Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms
A study testing Dietary Supplement with Proprietary Herbal Extract Blend and GABA in people with Menopausal Symptoms, run by Olly, PBC at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use. 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
- Menopausal Symptoms
- What is being tested?
- Dietary Supplement with Proprietary Herbal Extract Blend and GABA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 24 Jun 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 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 flushes 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
- BMI 20-40 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 subject's health under risk.
- Employees of the institute
- 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
- BP ≥160/110 mmHg
- Oophorectomy or amenorrhea > two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled Clinical Study to Examine the Clinical Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms
The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
- Conditions
- Menopausal Symptoms
- Being tested
- Placebo, Dietary Supplement with Proprietary Herbal Extract Blend and GABA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Eligible subjects will receive Placebo to take daily for five weeks
Dietary Supplement with Proprietary Herbal Extract Blend and GABADietary supplement
Eligible subjects will receive active product to take daily for five weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Dietary Supplement with Actives | Active comparator | Not described Receives: Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of symptom scores in Daily Dairy
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Measured: from enrollment to the end of study at five weeks
Changes of symptom scores in Mobile Application
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Measured: from enrollment to the end of study at five weeks
Secondary outcomes (5)
Changes in Menopause-Specific Quality of Life (MENQOL) Scores
To assess changes in mood and quality of life scores of the product compared to placebo
Measured: from enrollment to the end of study at five weeks
Changes in Green Climacteric Scale (GCS) Scores
To assess changes in mood scores of the product compared to placebo
Measured: from enrollment to the end of study at five weeks
Changes in Perceived Stress Scale (PSS) Scores
To assess changes in mood scores of the product compared to placebo
Measured: from enrollment to the end of study at five weeks
Changes in Profile of Mood States (POMS) Scores
To assess changes in mood scores of the product compared to placebo
Measured: from enrollment to the end of study at five weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
To assess changes in sleep scores of the product compared to placebo
Measured: from enrollment to the end of study at five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 May 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SymptomsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olly, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787443
- Sponsor's protocol ID
- UNLV20240222
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2024
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Clinical Study to Examine the Clinical Benefits of an Oral Product in Subjects With Menopausal Symptoms Including Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT06787443
- Acronym / sponsor ID
- UNLV20240222
- Conditions
- Menopausal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 22 Jan 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.
The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Dietary Supplement with Actives | Active comparator | Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA |
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 flushes 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
- BMI 20-40 kg/m2
- Able to read, understand, and complete the study questionnaire and records.
Key exclusion criteria (13 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 |
|---|---|---|
| PlaceboEligible subjects will receive Placebo to take daily for five weeks | Dietary supplement | Placebo |
| Dietary Supplement with Proprietary Herbal Extract Blend and GABAEligible subjects will receive active product to take daily for five weeks | Dietary supplement | Dietary Supplement with Actives |
Primary outcome
Changes of symptom scores in Daily Dairy
Time frame: from enrollment to the end of study at five weeks
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
Changes of symptom scores in Mobile Application
Time frame: from enrollment to the end of study at five weeks
To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects
5 secondary outcomes
Changes in Menopause-Specific Quality of Life (MENQOL) Scores
Time frame: from enrollment to the end of study at five weeks
Changes in Green Climacteric Scale (GCS) Scores
Time frame: from enrollment to the end of study at five weeks
Changes in Perceived Stress Scale (PSS) Scores
Time frame: from enrollment to the end of study at five weeks
Changes in Profile of Mood States (POMS) Scores
Time frame: from enrollment to the end of study at five weeks
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: from enrollment to the end of study at five 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 22 Jan 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. 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 Dietary Supplement with Proprietary Herbal Extract Blend and GABA in people with Menopausal Symptoms, 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 13 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 22 Jan 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?
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 of symptom scores in Daily Dairy (time frame: from enrollment to the end of study at five weeks). The study lists 2 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 22 Jan 2025.