Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause

Condition(s) studied

Investigational drug(s) / intervention(s)

Plant Extract-Based Dietary Supplement: A dietary supplement containing plant extracts, supplied by Monteloeder and administered daily for 12 weeks.

Placebo: Placebo administered daily for 12 weeks as the control intervention.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change From Baseline in Menopause Rating Scale (MRS) Total Score — Baseline and Week 12
  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.
• Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Domain Scores — Baseline and Weeks 4, 8, and 12
  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.

Trial sites (1)

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