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NCT Number: NCT07596069

Prevalence of Menopause-associated Symptoms Throughout the Menopausal Transition in Women Aged 40 to 70 Residing in Spain and Its Relationship With Physical Activity - MdH Study

The goal of this observational study is to learn about menopause-related symptoms in women aged 40 to 70 years who live in Spain. The study will also look at whether physical activity, body weight, health history, social factors, and risk of osteoporotic fracture are linked to these symptoms.

Menopause-related symptoms can affect daily life, sleep, mood, sexual health, and physical well-being. These symptoms may be different depending on whether a woman is in premenopause, perimenopause, or postmenopause. This study aims to better understand these symptoms in women living in Spain and to explore whether women who are more physically active report fewer or less bothersome symptoms.

The main questions this study aims to answer are:

How common are menopause-related symptoms in women aged 40 to 70 years who live in Spain? Do symptoms differ between women in premenopause, perimenopause, and postmenopause? Are women with higher levels of physical activity less likely to report bothersome menopause-related symptoms? Are body weight, age, health history, social factors, or osteoporotic fracture risk linked to more bothersome symptoms? Can the study identify groups of women who may be more likely to have a higher symptom burden?

Participants will complete an online survey one time. The survey will take about 15 to 25 minutes. Participants will answer questions about:

Age, place of residence, education, work situation, and other personal information Weight and height Menstrual history and reproductive history Current menopause stage Health history and current treatments Tobacco and alcohol use Type, amount, and setting of physical activity Time spent sitting Menopause-related symptoms during the last month Factors related to osteoporotic fracture risk, such as previous fractures, family history of hip fracture, smoking, alcohol use, use of corticosteroids, rheumatoid arthritis, and other health conditions

The survey will include three standard questionnaires. The Menopause-Specific Quality of Life Questionnaire will ask about symptoms in four areas: hot flashes and sweating, mood and social well-being, physical symptoms, and sexual health. The International Physical Activity Questionnaire will ask about physical activity during the last 7 days, including activity at work, transport, household tasks, leisure time, and time spent sitting. The Fracture Risk Assessment Tool will estimate the risk of osteoporotic fracture using clinical risk factors.

This is an observational study. Researchers will not assign participants to any treatment, exercise program, or medical care. The study will collect information through online questionnaires and will analyze links between menopause-related symptoms, physical activity, fracture risk, and other participant characteristics.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Cuerpos Serranos S.L., Madrid, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex.
  • Age 40 to 70 years.
  • Residence in Spain.
  • Ability to understand and complete the online questionnaire.

Exclusion criteria

  • Failure to provide electronic informed consent.
  • Inability to understand the study information or complete the online questionnaire in Spanish.

Treatment and study plan

Reproductive stage

Other

Participants will be classified according to the Stages of Reproductive Aging Workshop + 10 criteria. Based on self-reported menstrual history and reproductive information, participants will be classified as being in premenopause, early perimenopause, late perimenopause, early postmenopause, or late postmenopause. Reproductive stage will be analyzed as an exposure of interest in relation to menopause-related symptoms, physical activity, and osteoporotic fracture risk.

physical activity level

Behavioral

Physical activity will not be assigned by the researchers. Participants will report their usual physical activity during the last 7 days using the International Physical Activity Questionnaire (long version). Physical activity will be analyzed as an exposure of interest in relation to menopause-related symptoms.

Primary outcomes

  1. Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire

    Time frame: At baseline, through one online survey

    Menopause-related symptoms will be assessed using the Menopause-Specific Quality of Life Questionnaire. This questionnaire evaluates symptoms across four domains: vasomotor, psychosocial, physical, and sexual. For each domain, researchers will describe symptom prevalence, defined as the proportion of participants reporting one or more symptoms, and symptom severity, based on the level of bother reported by participants for each symptom. Domain scores will be analyzed separately, and an overall symptom score may also be analyzed when appropriate.

Secondary outcomes

  1. Association between physical activity level and menopause-related symptom prevalence and severity

    Time frame: At baseline, through one online survey

    The association between physical activity level and menopause-related symptom prevalence and severity will be assessed using the International Physical Activity Questionnaire and the Menopause-Specific Quality of Life Questionnaire. Physical activity will be measured during the last 7 days and expressed as metabolic equivalent task minutes per week. Participants will also be classified as having low, moderate, or high physical activity according to International Physical Activity Questionnaire scoring rules. This outcome will assess whether menopause-related symptom prevalence and severity differ according to overall physical activity level.

  2. Association between exercise type and frequency and menopause-related symptom prevalence and severity

    Time frame: At baseline, through one online survey

    The association between exercise type and frequency and menopause-related symptom prevalence and severity will be assessed using self-reported exercise questions and the Menopause-Specific Quality of Life Questionnaire. Participants will report whether they perform regular exercise, the main type of exercise they do, and the number of days per week they perform aerobic exercise and/or strength exercise. Exercise type will be classified as no regular exercise, mainly aerobic exercise, mainly strength exercise, or combined aerobic and strength exercise. This outcome will assess whether menopause-related symptom prevalence and severity differ according to exercise type and weekly exercise frequency.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Belén Peinado, PhD

CONTACT

[email protected]

910677988 ext. +34

Javier Butragueño, PhD

CONTACT

[email protected]

648785150 ext. +34

Sponsors and collaborators

Lead sponsor

Cuerpos Serranos S.L.

Industry

Collaborators

  • Universidad Politecnica de Madrid

Registry information

Official study title

Prevalence of Menopause-associated Symptoms Throughout the Menopausal Transition in Women Aged 40 to 70 Residing in Spain and Its Relationship With Physical Activity.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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