ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women (NCT07580846) | Clinical Trial Compass
RecruitingNot Applicable
ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women
Spain100 participantsStarted 2026-03-20
Plain-language summary
This is a prospective, multicenter, observational clinical study conducted under routine clinical practice conditions aimed at describing adherence to a creatine-based nutritional supplement (Creaticare FEM) in estrogen-depleted adult women. Participants will receive the supplement for 12 weeks, and adherence will be assessed as the percentage of doses consumed and the proportion of participants achieving ≥80% adherence. Secondary outcomes include persistence, satisfaction, tolerability, and adherence to recommended physical activity. Exploratory outcomes include changes in muscle strength, body composition, quality of life, joint pain, and skin health.
Who can participate
Age range
40 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biological female sex.
* Age ≥40 years.
* Estrogen-depleted status, defined as at least one of the following:
natural menopause, defined as amenorrhea for ≥12 consecutive months; surgically induced menopause; late perimenopause with elevated FSH according to clinical judgment.
* Absence of major comorbidities that would contraindicate use of the nutritional supplement or the recommended physical activity.
* No relevant changes in usual treatment during the previous 3 months.
* Ability to understand the study information and provide written informed consent.
* Willingness to take the nutritional supplement according to the study instructions.
* Willingness to follow general physical activity recommendations provided by the investigator.
* Willingness and ability to attend the planned visits and complete study assessments through Week 12.
Exclusion Criteria:
* Initiation or modification of treatment with GLP-1 receptor agonists within the previous 12 weeks.
* Presence of musculoskeletal or joint conditions that significantly limit the ability to perform regular physical activity or study-related functional assessments.
* Clinically relevant renal or hepatic disease.
* Current use of diuretics or potentially nephrotoxic medications.
* Known allergy or intolerance to any component of the nutritional supplement.
* Participation in another clinical study (nutritional, pharmacological, or interventional) within the previous 3 months.
* Any medical conditio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence