The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause symptoms-such as joint discomfort, hot flashes and night sweats-in women aged 50-70. The primary research question is whether taking the study product daily for 12 weeks can reduce the severity and frequency of menopause-related symptoms.
About 250 women across the U.S. will take part in this study. Participants will be randomly placed into one of two groups-one will take the active study product, and the other will take a placebo. All participants will take two tablets each morning for about 12 weeks. The total time the participant will be in the study is about 14 weeks, including the time it takes to collect baseline values. All parts of the study are done virtually, in-person visits are not required. The participant will take part in five virtual check-ins, including a screening visit, a baseline visit, two check-ins during the study, and a final visit at the end. Throughout the study, the participant will be asked to complete daily diaries and weekly and monthly questionnaires to report on their symptoms and how they are feeling. These will include questions 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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Bonafide Health
Harrison, New York, United States
RECRUITINGChange from Baseline in Menopause Related Quality of Life Outcomes
Change from baseline in scores for severity of perceived joint discomfort, frequency of perceived joint discomfort, perceived joint mobility and perceived daily mobility assessed via a Visual Analog Scale (VAS). Response options will range from 0-100, with a higher score reflecting the worse outcome.
Time frame: From enrollment to the end of study at 12 weeks
Change from Baseline in Menopause Related Quality of Life Outcomes
Change from baseline in scores for Arthralgia Inventory (PRAI) score. The rating scale ranges from 0-10, with a higher score indicating a worse outcome.
Time frame: From enrollment to the end of study at 12 weeks
Change from Baseline in Menopause Related Quality of Life Outcomes
Change from baseline in scores for Musculoskeletal Health Questionnaire (MSK-HQ) score. Each response ranges from "not at all" to "very severe", with a higher score indicating a better outcome.
Time frame: From enrollment to the end of study at 12 weeks
Change from Baseline on Overall Menopausal Symptoms
Change from baseline in scores for the following: Menopause Specific Quality of Life Questionnaire (MENQOL). Each question being scored from 0 to 6, with 6 being the worse outcome.
Time frame: From enrollment to the end of study at 12 weeks
Change from Baseline on Overall Menopausal Symptoms
Change from baseline in scores for Menopausal Rating Scale (MRS).Each question is rated on a 5-point scale with the higher number correlating with the more severe symptoms and worse outcome.
Time frame: From enrollment to the end of study at 12 weeks
Change from Baseline on Overall Menopausal Symptoms
Change from baseline in the frequency of menopause related hot flashes assessed via daily diaries. Daily diaries include the number of total vasomotor occurrences, the severity of total vasomotor occurrences and the number of times awoke during the night due to night sweat occurrences.
Time frame: From enrollment to the end of study at 12 weeks
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