Oral supplement for menopausal vasomotor symptoms
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).
This study will test whether an oral dietary supplement can reduce hot flashes and other menopausal symptoms in healthy women aged 40 to 65 who have frequent hot flashes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Olly, PBC Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07033013 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, single-center trial with a run-in baseline period. Eligible participants will take either the active oral dietary supplement or a matching placebo and complete daily hot flash diaries and validated questionnaires including the Greene Climacteric Scale. The study enrolls healthy women aged 40–65 who report more than five hot flashes per day and meet BMI and other eligibility criteria. Outcomes will compare changes in vasomotor symptoms and questionnaire scores between the supplement and placebo groups.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 40–65 who are perimenopausal or menopausal with at least five hot flashes per day for the prior 60 days, BMI under 30, not using hormone therapy, and willing to attend study visits in San Francisco.
Not a fit: Patients unlikely to benefit include those who are pregnant or breastfeeding, on hormone replacement therapy, have had a hysterectomy, have immune insufficiency, or do not experience frequent hot flashes.
Why it matters
Potential benefit: If effective, the supplement could offer a non-hormonal option to reduce hot flashes and improve menopause-related symptoms.
How similar studies have performed: Prior trials of various non-hormonal dietary supplements for menopausal vasomotor symptoms have produced mixed and inconsistent results, with only modest benefits reported in some studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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: * 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. * 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
Where this trial is running
San Francisco, California
- San Francisco Research Institute — San Francisco, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.