← Back to all trials
Recruiting
NCT07863973
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Conditions: Perimenopause, Postmenopause, Hot Flashes
Sex: Female
Ages: 42 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: University of Alicante
Location: European Institute Of Exercise and Health Elche Alicante
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 Criteria
Inclusion Criteria:
* Women aged 42 to 60 years.
* Late perimenopause or early postmenopause.
* Amenorrhea for at least 3 months and no more than 10 years since menopause.
* At least five moderate or severe hot flashes per day during the screening period.
* Body mass index of 35 kg/m² or less.
* Written informed consent.
Exclusion Criteria:
* Serious uncontrolled diseases.
* Treatments that may interfere with the assessment of the primary outcome measures.
* Known allergy or intolerance to any component of the study product.
* Concurrent participation in another clinical trial.
* Any circumstance that, in the investigator's judgment, would hinder compliance with the study protocol.
Source: ClinicalTrials.gov (NCT07863973). StuddyBuddy aggregates publicly available trial information.