NCT07580846 ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women
| NCT ID | NCT07580846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Margan Biotech |
| Condition | Menopause |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-03-20 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 condition or social circumstance that, in the investigator's judgment, could interfere with study participation, adherence, or data validity.
Contact & Investigator
Silvia P Gonzalez, Doctor
STUDY DIRECTOR
Menoclinica by Palacios
Frequently Asked Questions
Who can join the NCT07580846 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 75 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580846 currently recruiting?
Yes, NCT07580846 is actively recruiting participants. Contact the research team at silvia.martinez@marganbiotech.com for enrollment information.
Where is the NCT07580846 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain, Madrid, Spain, Málaga, Spain.
Who is sponsoring the NCT07580846 clinical trial?
NCT07580846 is sponsored by Margan Biotech. The principal investigator is Silvia P Gonzalez, Doctor at Menoclinica by Palacios. The trial plans to enroll 100 participants.