Menopausal SymptomsNCT07596069
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
An observational study of Menopausal Symptoms and Physical Activity and Sedentary Behavior, run by Cuerpos Serranos S.L. at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Symptoms, Physical Activity and Sedentary Behavior
- What is being tested?
- Reproductive stage and Physical Activity Level
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15,000 participants
- Where
- 2 sitesSpain
- Study dates
- 18 Apr 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include women aged 40 to 70 years who live in Spain. Participants will be recruited from the community through online dissemination channels, including institutional websites, social media, digital communication channels, press announcements, links, and QR codes. Interested women will access the study website, review the study information, provide electronic informed consent, and complete the online questionnaire. Participants will be classified by reproductive stage using the Stages of Reproductive Aging Workshop + 10 criteria, based on self-reported menstrual and reproductive information collected in the questionnaire. Categories will include premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause. Some participants may not be classifiable into a reproductive stage based only on questionnaire data. This may occur when the available self-reported information is not sufficient to apply STRAW+10.
Who may be able to join
- Female sex.
- Age 40 to 70 years.
- Residence in Spain.
- Ability to understand and complete the online questionnaire.
Who cannot join
- Failure to provide electronic informed consent.
- Inability to understand the study information or complete the online questionnaire in Spanish.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Cuerpos Serranos S.L.
Madrid
Javier Butragueño, PhD, 648785150 ext. +34, javier.butragueno@gmail.com
María Ángeles García, PhD, info@cuerposserranos.com
- Recruiting
Universidad Politécnica de Madrid
Madrid
Ana Belén Peinado, PhD, 910677988 ext. +34, anabelen.peinado@upm.es
About this study
Official 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.
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.
Read more
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.
- Being tested
- Reproductive stage, Physical Activity Level
- Keywords
- Menopausal Symptoms, Women Reproductive Stages, Menopause, Perimenopause, Women's health, Spanish Women, Physical activity, Menopause transition, Vasomotor symptoms, Mood symptoms, Osteoporotic fracture risk, IPAQ, MENQOL, FRAX, Exercise habits
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive stageOther
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 LevelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Women aged 40 to 70 years living in Spain | Participants will complete one online survey about menopause-related symptoms, physical activity, reproductive and menstrual history, health history, anthropometric information, lifestyle factors, and osteoporotic fracture risk. For the primary outcome analysis, participants will be classified into five reproductive stage groups using the Stages of Reproductive Aging Workshop + 10 criteria: premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause. Receives: Other: Reproductive stage; Behavioral: Physical Activity Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire
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.
Measured: At baseline, through one online survey
Secondary outcomes (2)
Association between physical activity level and menopause-related symptom prevalence and severity
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.
Measured: At baseline, through one online survey
Association between exercise type and frequency and menopause-related symptom prevalence and severity
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.
Measured: At baseline, through one online survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cuerpos Serranos S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Responsible party
- Sponsor
- Investigators
- María Ángeles García, PhD, Principal investigator, Cuerpos Serranos S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596069
- Sponsor's protocol ID
- ABPL-20260311
- Status last verified
- Jul 2026
- First submitted
- 5 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the study collects sensitive health, reproductive, and lifestyle information. Study results will be shared in aggregate and anonymized form through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07596069
- Acronym / sponsor ID
- ABPL-20260311
- Keywords
- Menopausal Symptoms, Women Reproductive Stages, Menopause, Perimenopause, Women's health, Spanish Women, Physical activity, Menopause transition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Cuerpos Serranos S.L.Industry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 40 to 70 years living in Spain | – | Other: Reproductive stage, Behavioral: Physical Activity LevelParticipants will complete one online survey about menopause-related symptoms, physical activity, reproductive and menstrual history, health history, anthropometric information, lifestyle factors, and osteoporotic fracture risk. For the primary outcome analysis, participants will be classified into five reproductive stage groups using the Stages of Reproductive Aging Workshop + 10 criteria: premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include women aged 40 to 70 years who live in Spain. Participants will be recruited from the community through online dissemination channels, including institutional websites, social media, digital communication channels, press announcements, links, and QR codes. Interested women will access the study website, review the study information, provide electronic informed consent, and complete the online questionnaire. Participants will be classified by reproductive stage using the Stages of Reproductive Aging Workshop + 10 criteria, based on self-reported menstrual and reproductive information collected in the questionnaire. Categories will include premenopause, early perimenopause, late perimenopause, early postmenopause, and late postmenopause. Some participants may not be classifiable into a reproductive stage based only on questionnaire data. This may occur when the available self-reported information is not sufficient to apply STRAW+10.
Key inclusion criteria (4 listed)
- Female sex.
- Age 40 to 70 years.
- Residence in Spain.
- Ability to understand and complete the online questionnaire.
Key exclusion criteria (2 listed)
- Failure to provide electronic informed consent.
- Inability to understand the study information or complete the online questionnaire in Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reproductive stageParticipants 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. | Other | Women aged 40 to 70 years living in Spain |
| Physical Activity LevelPhysical 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. | Behavioural | Women aged 40 to 70 years living in Spain |
Primary outcome
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.
2 secondary outcomes
Association between physical activity level and menopause-related symptom prevalence and severity
Time frame: At baseline, through one online survey
Association between exercise type and frequency and menopause-related symptom prevalence and severity
Time frame: At baseline, through one online survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the study collects sensitive health, reproductive, and lifestyle information. Study results will be shared in aggregate and anonymized form through scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Ángeles García, PhD principal investigator
Cuerpos Serranos S.L.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Symptoms and Physical Activity and Sedentary Behavior, run by Cuerpos Serranos S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Belén Peinado, PhD (910677988 ext. +34, anabelen.peinado@upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and severity of menopause-related symptoms assessed by the Menopause-Specific Quality of Life Questionnaire (time frame: At baseline, through one online survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.