MenopauseNCT06289907
Hot Flash and Night Sweat Virtual Study
A study testing Bonafide-HF3.0 in people with Menopause, run by Bonafide Health at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Bonafide-HF3.0
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy women who are 40 to 65 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 (perimenopause, post-menopause).
- Have self-reported at least 5 moderate to severe vasomotor symptoms (hot flashes and/or night sweats) most days of the week.
- 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 concomitant meds section within 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.
Who cannot join
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Currently incarcerated prisoners
- Use of any treatment for menopausal symptoms or other concomitant treatments listed in Section 11.4.
- Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
- Received a vaccine for COVID-19 in the two weeks prior to screening or planning to receive 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).
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- History of cancer (except localized skin cancer without metastases) within 1 year 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/antibiotics (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 3 years.
- Use of any vaginal medications, rinses, or moisturizers, or other items including 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of BH-HF3.0 on Vasomotor Symptoms (VMS) in Menopausal Women: A De-Centralized, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65.
Read the detailed description
Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 51 years of age or older. Although menopause can be induced through procedures such as bilateral oophorectomy with or without hysterectomy and other medications, it most commonly occurs with the natural loss and depletion of ovarian follicles through aging. Common symptoms of menopause include changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS).
Vasomotor symptoms (VMS), which include hot flashes and night sweats, occur in women at or around the time of menopause. Most women will experience these symptoms during the years surrounding their final menstrual period; however, there are some women that report VMS that persist for decades. The pathogenesis of VMS has not been fully understood, but the pathways involving estrogen, norepinephrine, and serotonin are hypothesized to cause altered homeostatic thermoregulatory mechanisms. VMS can have a negative impact on quality of life by disrupting both sleep and mood.4 About one-third of women in the United States are older than 50 years of age, the typical age of onset. Approximately 75% of women in this age group (i.e., 40 to 50 million currently) will experience hot flashes.
Treatments for VMS range significantly from prescription medications to over-the-counter therapies (non-prescription) to lifestyle modifications. Hormone replacement therapy (HRT) still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen-progestin-containing products, reduces the frequency and severity of hot flashes by 75-79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern, it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible, based on individual circumstances and needs. Additionally, many healthcare practitioners and patients seek alternative solutions to HRT for personal and medical reasons. Alternatives to HRT vary from hypnosis and dietary supplements, including vitamin E, black cohosh, and phytoestrogens, all which drastically differ in their VMS mitigation effectiveness. There is a need for an effective and safe treatment of VMS for menopausal women, and dietary supplements may fill this role.
The SP for this study is Bonafide Health's Bonafide-HF3.0. Bonafide-HF3.0 contains green tea extract (GTE), curcumin, and phycocyanin sourced from Spirulina "Blue-Green" algae.
This double-blind placebo-controlled (DBPC) study will be conducted to evaluate the effectiveness of Bonafide-HF3.0 on vasomotor symptoms and overall menopausal symptoms in healthy women, aged 40-65, who are perimenopausal and menopausal.
- Conditions
- Menopause
- Being tested
- Bonafide-HF3.0, Placebo
- Keywords
- Menopause, Hot Flashes, Night Sweats
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonafide-HF3.0Dietary supplement
Take 2 capsules once daily in the mornings with food
PlaceboDietary supplement
Take 2 capsules once daily in the mornings with food
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity Receives: Dietary Supplement: Bonafide-HF3.0 |
| Placebo group | Placebo comparator | Placebo capsule containing:
* Microcrystalline cellulose
* Silicon dioxide micronized
* Magnesium stearate Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms
The number and severity of hot flashes assessed via participant diary tracking (electronic)
Measured: 12 weeks
To determine the effects of the SP compared to placebo on hot flash symptoms
The number and severity of night sweats assessed via participant diary tracking (electronic)
Measured: 12 weeks
To determine the effects of the SP compared to placebo on hot flash symptoms
Change from baseline for the Hot Flash Related Daily Interference Scale (HFRDIS) scores at EOS
Measured: 12 weeks
To determine the effects of the SP compared to placebo on vasomotor symptoms
Change from baseline for the Visual Analog Scale (VAS) Vasomotor Symptoms Questionnaire at EOS
Measured: 12 weeks
To determine the effects of the SP compared to placebo on overall menopausal symptoms
Change from baseline for the Menopausal Rating Scale (MRS) in scores at EOS
Measured: 12 weeks
To determine the effects of the SP compared to placebo on overall menopausal symptoms
Change from baseline for the Visual Analog Scale (VAS) Menopausal Symptoms Questionnaire in scores at EOS
Measured: 12 weeks
To determine the effects of the SP compared to placebo on quality of life
Change from baseline in Menopause-Specific Quality of Life (MENQOL) scores
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start9 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Decentralized, double-blind, placebo-controlled, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bonafide Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Trisha VanDusseldorp, Ph.D., Study director, Bonafide Health, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289907
- Sponsor's protocol ID
- LH-BH-ADV-01
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BH-HF3.0 on Vasomotor Symptoms (VMS) in Menopausal Women: A De-Centralized, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06289907
- Acronym / sponsor ID
- LH-BH-ADV-01
- Conditions
- Menopause
- Keywords
- Menopause, Hot Flashes, Night Sweats
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bonafide HealthIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 9 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65.
Detailed description
Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 51 years of age or older. Although menopause can be induced through procedures such as bilateral oophorectomy with or without hysterectomy and other medications, it most commonly occurs with the natural loss and depletion of ovarian follicles through aging. Common symptoms of menopause include changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS).
Vasomotor symptoms (VMS), which include hot flashes and night sweats, occur in women at or around the time of menopause. Most women will experience these symptoms during the years surrounding their final menstrual period; however, there are some women that report VMS that persist for decades. The pathogenesis of VMS has not been fully understood, but the pathways involving estrogen, norepinephrine, and serotonin are hypothesized to cause altered homeostatic thermoregulatory mechanisms. VMS can have a negative impact on quality of life by disrupting both sleep and mood.4 About one-third of women in the United States are older than 50 years of age, the typical age of onset. Approximately 75% of women in this age group (i.e., 40 to 50 million currently) will experience hot flashes.
Treatments for VMS range significantly from prescription medications to over-the-counter therapies (non-prescription) to lifestyle modifications. Hormone replacement therapy (HRT) still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen-progestin-containing products, reduces the frequency and severity of hot flashes by 75-79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern, it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible, based on individual circumstances and needs. Additionally, many healthcare practitioners and patients seek alternative solutions to HRT for personal and medical reasons. Alternatives to HRT vary from hypnosis and dietary supplements, including vitamin E, black cohosh, and phytoestrogens, all which drastically differ in their VMS mitigation effectiveness. There is a need for an effective and safe treatment of VMS for menopausal women, and dietary supplements may fill this role.
The SP for this study is Bonafide Health's Bonafide-HF3.0. Bonafide-HF3.0 contains green tea extract (GTE), curcumin, and phycocyanin sourced from Spirulina "Blue-Green" algae.
This double-blind placebo-controlled (DBPC) study will be conducted to evaluate the effectiveness of Bonafide-HF3.0 on vasomotor symptoms and overall menopausal symptoms in healthy women, aged 40-65, who are perimenopausal and menopausal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Decentralized, double-blind, placebo-controlled, randomized
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Dietary Supplement: Bonafide-HF3.0Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule containing: * Microcrystalline cellulose * Silicon dioxide micronized * Magnesium stearate |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy women who are 40 to 65 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 (perimenopause, post-menopause).
- Have self-reported at least 5 moderate to severe vasomotor symptoms (hot flashes and/or night sweats) most days of the week.
- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
Key exclusion criteria (16 listed)
- Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- Currently incarcerated prisoners
- Use of any treatment for menopausal symptoms or other concomitant treatments listed in Section 11.4.
- Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.
- Received a vaccine for COVID-19 in the two weeks prior to screening or planning to receive 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bonafide-HF3.0Take 2 capsules once daily in the mornings with food | Dietary supplement | Active group |
| PlaceboTake 2 capsules once daily in the mornings with food | Dietary supplement | Placebo group |
Primary outcome
To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms
Time frame: 12 weeks
The number and severity of hot flashes assessed via participant diary tracking (electronic)
To determine the effects of the SP compared to placebo on hot flash symptoms
Time frame: 12 weeks
The number and severity of night sweats assessed via participant diary tracking (electronic)
To determine the effects of the SP compared to placebo on hot flash symptoms
Time frame: 12 weeks
Change from baseline for the Hot Flash Related Daily Interference Scale (HFRDIS) scores at EOS
To determine the effects of the SP compared to placebo on vasomotor symptoms
Time frame: 12 weeks
Change from baseline for the Visual Analog Scale (VAS) Vasomotor Symptoms Questionnaire at EOS
To determine the effects of the SP compared to placebo on overall menopausal symptoms
Time frame: 12 weeks
Change from baseline for the Menopausal Rating Scale (MRS) in scores at EOS
To determine the effects of the SP compared to placebo on overall menopausal symptoms
Time frame: 12 weeks
Change from baseline for the Visual Analog Scale (VAS) Menopausal Symptoms Questionnaire in scores at EOS
To determine the effects of the SP compared to placebo on quality of life
Time frame: 12 weeks
Change from baseline in Menopause-Specific Quality of Life (MENQOL) scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha VanDusseldorp, Ph.D. study director
Bonafide Health, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonafide-HF3.0 in people with Menopause, run by Bonafide Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.