One Week Clinical Study in Subjects With Menopausal Symptoms
NCT ID: NCT06794021
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2025-01-21
2025-04-22
Brief Summary
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1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application
2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application
3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL).
4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo
Oral dietary supplement. 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.
Placebo
Eligible subjects will receive Placebo to take daily for seven days
Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Oral dietary supplement. 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.
Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Eligible subjects will receive active product to take daily for seven days
Interventions
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Dietary Supplement with Proprietary Herbal Extract Blend and GABA
Eligible subjects will receive active product to take daily for seven days
Placebo
Eligible subjects will receive Placebo to take daily for seven days
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
* Employees of the institute or the brand owner or the manufactures of the product
* 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
* BP ≥160/110 mmHg
* Oophorectomy or amenorrhea \> two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.
40 Years
65 Years
FEMALE
Yes
Sponsors
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Olly, PBC
INDUSTRY
Responsible Party
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Locations
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San Francisco Research Institute
San Francisco, California, United States
Countries
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Other Identifiers
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UNLV20241205
Identifier Type: -
Identifier Source: org_study_id
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