Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

Completed · Not applicable

Conditions studied: Hot Flashes, Hot Flash, Hot Flushes, Menopause, Postmenopause, Hot Flushes and/or Sweats, Hot Flushes, Night Sweats, Vasomotor Symptoms, Vasomotor Symptoms (VMS), Vasomotor Symptoms Associated With Menopause

In brief

The goal of this study is to evaluate the efficacy of a neurokinin 1,3 antagonist on improving vasomotor symptoms (VMS) and overall menopause symptoms in women between the ages of 40-70. The primary research question is whether taking the study product daily for 4 weeks with an optional 8 week extension, significantly reduces the severity and frequency of menopause-related symptoms.

Key facts

Study ID

NCT07408115

Run by

Bonafide Health

People needed

112

Starts

2024-05-24

Expected to finish

2024-12-18

Last updated by the study team

2026-02-12

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Healthy women who are 40 to 70 years of age (inclusive).
• Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
• Have self-reported menopausal symptoms for the past 6 months.
• Have self-reported ≥5 moderate to severe hot flashes per day, on average for 7 days.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Agree to refrain from treatments listed in the defined timeframe.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if…

• Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• Use of any treatment for menopausal symptoms or other concomitant treatments listed.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
• History of cancer (except localized skin cancer without metastases) within two years prior to screening.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastric bypass procedures, or pancreatic insufficiency).
• Active vaginal infections/abnormalities (e.g., active urinary tract infection (UTI), genital hemorrhage of unknown origin, pelvic inflammatory disease (PID)). Note: screened participants with infections would be eligible to participate two weeks after completing their treatment (wash-out period).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• Major surgery in three months prior to screening or planned major surgery during the study.
• History of alcohol or substance abuse in the last 5 years.
• Use of any vaginal medications, cooling devices, cooling mattresses, cooling sprays, or patches purposed for hot flash control (i.e., V-qool patch, estrogen cream, etc.) one week before and during study. Note: Screened participants that are willing to undergo a washout of at least two weeks or possibly longer and abstain from using above products during the duration of their participation will be enrolled.
• Previous participation in a Bonafide Health run clinical trial on Hot Flashes using Bonafide HF-3.0.
• Participation in another clinical or research trial.
• Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
• Currently incarcerated prisoners.

Where it is running

• Bonafide Health — Harrison, New York, United States

Full record on ClinicalTrials.gov

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