Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289907
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Brief Title:
Hot Flash and Night Sweat Virtual Study
Sponsor:
Bonafide Health
Organization:
Bonafide Health
Study Overview
Official Title:
Effect of BH-HF30 on Vasomotor Symptoms VMS in Menopausal Women A De-Centralized Randomized Double-Blinded Placebo-Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Menopause is characterized by the cessation of menstruation for 12 consecutive months It is a natural phase in which a womens 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 mood4 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 ie 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 Healths Bonafide-HF30 Bonafide-HF30 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-HF30 on vasomotor symptoms and overall menopausal symptoms in healthy women aged 40-65 who are perimenopausal and menopausal
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 mood4 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 ie 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 Healths Bonafide-HF30 Bonafide-HF30 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-HF30 on vasomotor symptoms and overall menopausal symptoms in healthy women aged 40-65 who are perimenopausal and menopausal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None