Study of the Effect of a Dietary Supplement on Health Indicators in Women With Late Perimenopause and Early Postmenopause
Sponsor study identifier
interventional
120
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study will evaluate the effects of a plant extract-based dietary supplement on menopausal symptoms and health indicators in women with late perimenopause or early postmenopause. Approximately 120 women aged 42 to 60 years will be randomly assigned to receive either the dietary supplement or a placebo daily for 12 weeks. Neither the participants nor the research team will know the assigned treatment during the study. Assessments will include the frequency and severity of hot flashes and night sweats, menopausal symptoms, quality of life, sleep quality, emotional well-being, body composition, and selected laboratory parameters.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2026
Actual (reported)October 7, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change From Baseline in Menopause Rating Scale (MRS) Total Score
Change in menopausal symptom severity assessed using the Menopause Rating Scale (MRS). The questionnaire includes 11 items scored from 0 to 4, with a total score ranging from 0 to 44. Higher scores indicate more severe symptoms.
Baseline and Week 12
Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Domain Scores
Change in menopause-related quality of life assessed using the MENQOL questionnaire across its vasomotor, psychosocial, physical, and sexual domains. Domain scores range from 1 to 8, with higher scores indicating greater symptom-related bother and poorer quality of life.
Baseline and Weeks 4, 8, and 12
Participants will receive a plant extract-based dietary supplement daily for 12 weeks.
Participants will receive placebo daily for 12 weeks.
A dietary supplement containing plant extracts, supplied by Monteloeder and administered daily for 12 weeks.
Placebo administered daily for 12 weeks as the control intervention.
European Institute Of Exercise and Health
Elche, Alicante, 03202, Spain
First Submitted
October 2, 2026
First Posted
October 7, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Baseline and Week 12
Number of Participants With Adverse Events
Throughout the 12-week intervention
Change From Baseline in Body Weight
Baseline and Weeks 4, 8, and 12
Change From Baseline in Body Mass Index
Baseline and Weeks 4, 8, and 12
Change From Baseline in Fasting Blood Glucose
Baseline and Week 12
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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