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New treatment option for Perimenopause
Official title Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health
ClinicalTrials.gov ID: NCT07251296
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only
You may be able to join if
- Women aged between 45 and 65 years.
- In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.
- Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.
- Regular nighttime sleep and not engaged in shift work.
- Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a...
You likely can't join if
- Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
- Surgical, induced, or early menopause (before age 40).
- Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics)...
- Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active...
- Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3...
- Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and/or updated medical report.
See the full eligibility criteria
- Women aged between 45 and 65 years.
- In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.
- Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.
- Regular nighttime sleep and not engaged in shift work.
- Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire.
- Body mass index (BMI) between 18.5 and 35 kg/m².
- Sufficient functional and cognitive capacity to participate in supervised physical exercise and follow the study protocol.
- Signed informed consent and availability to attend all scheduled sessions and assessments.
- Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).
- Surgical, induced, or early menopause (before age 40).
- Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other...
- Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders.
- Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.).
- Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and/or updated medical report.
- Simultaneous participation in another clinical trial or intervention program involving drugs, supplements, or structured physical exercise of any kind.
- Known allergy or intolerance to any component of the nutritional supplement to be administered.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.