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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
What this study is testing
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of hysterectomy
- Women on hormone replacement therapy
- Use of systemic corticosteroids or immunosuppressant drugs.
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.