CompletedNot Applicable

Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

United States112 participantsStarted 2024-05-24

Plain-language summary

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.

Who can participate

Age range

40 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Change from Baseline on Hot Flash Symptoms assessed via Hot Flash Related Daily Interference Scale (HFRDIS) scores.

Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Change from Baseline on Hot Flash Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).

Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Change from Baseline on Overall Menopausal Symptoms assessed via the Greene Climacteric Scale (CGS).

Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Change from Baseline on Overall Menopausal Symptoms assessed via the Menopause Rating Scale (MRS).

Timeframe: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Trial details

NCT IDNCT07408115

SponsorBonafide Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More Hot Flashes trials

Plain-language summary

Who can participate

Age range

40 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.