Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

Bonafide Health112 enrolled

Overview

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.

About 200 women across the U.S. will take part in this open label trial. All participants will take the study product and will be instructed to consume two tablets each morning for 4 weeks. Participants will be offered the option to enroll in an 8 week extension after the 4 week supplementation period. During this extension, participants will be asked to continue supplementing with the study product at the same dosing regimen. If a participant opts out of the extension, the total time the participant will be in the study is 5 weeks, including baseline data collection. If a participant opts into the 8 week extension, the total time the participant will be in the study is 12 weeks. This is a remotely-delivered trial with no in-person assessments. Participants will take part in four virtual check-ins, including a pre-screening visit, a screening visit, a baseline visit, and a initial end of study visit. If a participant opts into the 8 week extension, there will be two additional virtual visits that are each conducted 4 weeks apart, including a end-of-extension visit. Throughout the study, participants will be asked to complete daily diaries and weekly and monthly questionnaires to report on their symptoms and how they are feeling. Questions included in these assessments ask about hot flashes, night sweats, physical comfort, and overall well-being. The study is led by a research team based in Harrison, NY, USA.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy women who are 40 to 70 years of age (inclusive). 2. Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive). 3. Have self-reported menopausal symptoms for the past 6 months. 4. Have self-reported ≥5 moderate to severe hot flashes per day, on average for 7 days. 5. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product. 6. Agree to refrain from treatments listed in the defined timeframe. 7. 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. Exclusion Criteria: 1. Individuals who are lactating, pregnant, or planning to become pregnant during the study. 2. Use of any treatment for menopausal symptoms or other concomitant treatments listed. 3. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients. 4. 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). 5. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV). 6. History of cancer (except localized skin cancer without metastases) within two years prior to screening. 7. 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. 8. 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). 9. 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). 10. 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). 11. Major surgery in three months prior to screening or planned major surgery during the study. 12. History of alcohol or substance abuse in the last 5 years. 13. 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. 14. Previous participation in a Bonafide Health run clinical trial on Hot Flashes using Bonafide HF-3.0. 15. Participation in another clinical or research trial. 16. 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. 17. Currently incarcerated prisoners.

Outcomes

Primary Outcomes

Change from Baseline on Hot Flash Symptoms assessed by the number and severity of hot flashes and times awakened at night due to night sweats collected via participant diary tracking electronically.

Study diary will be completed by participants daily from Day -7 to -1 to establish a pre-dose baseline and then from Day 1 to Day 28 ± for the initial study duration. If a participant participates in the optional extension, they will be asked to continue completing the diaries for an additional 56 ± 3 days, for a total of 84 ± 3 days. The information recorded will be the number and severity of hot flashes that occurred, the number of night sweats and severity, any changes in concomitant medication/dietary supplement information, and any changes in health (Day 1 to 84 ± 3). Efficacy outcomes include daily diary results (number and severity of hot flashes and number of times awakened at night due to night sweats)