Hot Flash and Night Sweat Virtual Study

NCT06289907 | Unknown

• 1 other identifier: LH-BH-ADV-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Keywords

Menopause; Hot Flashes; Night Sweats

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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

  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

  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

  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

  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

  12 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity

Dietary Supplement: Bonafide-HF3.0

Placebo group

PLACEBO COMPARATOR

Placebo capsule containing: * Microcrystalline cellulose * Silicon dioxide micronized * Magnesium stearate

Dietary Supplement: Placebo

Interventions

Bonafide-HF3.0 DIETARY_SUPPLEMENT

Take 2 capsules once daily in the mornings with food

Active group

Placebo DIETARY_SUPPLEMENT

Take 2 capsules once daily in the mornings with food

Placebo group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Bonafide Health: lead
• Lindus Health: collaborator

Study Sites (1)

Lindus Health, Inc.

London, United Kingdom

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Trisha VanDusseldorp, Ph.D.

  Bonafide Health, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Decentralized, double-blind, placebo-controlled, randomized

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: July 9, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 4, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)