An observational study in Menopause and Estrogen Deficiency, sponsored by Margan Biotech. Recruiting at 4 sites in Spain. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Margan Biotech · Observational
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.
This is a prospective, multicenter, observational clinical study aimed at evaluating adherence to a creatine-based nutritional supplementation (Creaticare FEM) in estrogen-depleted adult women, including those in menopause or late perimenopause.
Creaticare FEM is a multi-ingredient dietary supplement formulated to support musculoskeletal, metabolic, and skin health in this population. The daily dose (10 g) contains creatine monohydrate (3 g), hydrolyzed collagen (5 g), hyaluronic acid (95 mg), beta-alanine (300 mg), magnesium (200 mg), and vitamins A, C, E, and B6.
Participants will receive the nutritional supplement for a period of 12 weeks, without any modification of standard clinical practice. The primary objective is to describe adherence to supplementation, defined as the percentage of prescribed doses consumed during the study period and the proportion of participants achieving high adherence (≥80%) at the end of follow-up.
Secondary objectives include the assessment of persistence with supplementation, participant-reported acceptability and satisfaction, tolerability through the monitoring of adverse events, and adherence to a general recommendation of physical activity provided as part of routine care.
In addition, exploratory analyses will be performed to describe pre-post changes over the 12-week period in selected clinical variables, including muscle strength (handgrip dynamometry), body composition (bioimpedance), quality of life (Cervantes questionnaire), joint pain (visual analog scale), and skin health perception (cosmetic VAS). These exploratory outcomes are descriptive in nature and intended to generate hypotheses for future controlled studies.
The study does not involve randomization, control group, or experimental intervention beyond routine supplementation, and therefore is not intended to establish causal relationships or confirm clinical efficacy, but rather to provide real-world evidence on adherence, acceptability, and tolerability of a multimodal nutritional supplement in this population.
Margan Biotech is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Estrogen-depleted adult women (menopause or late perimenopause) attending routine clinical practice consultations in participating centers and initiating nutritional supplementation.
natural menopause, defined as amenorrhea for ≥12 consecutive months; surgically induced menopause; late perimenopause with elevated FSH according to clinical judgment.
Exclusion Criteria:
Single prospective cohort of estrogen-depleted adult women (menopause or late perimenopause) receiving a creatine-based nutritional supplement for 12 weeks under routine clinical practice conditions. Participants take a daily dose of the supplement (10 g), which contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins A, C, E, and B6. In addition, participants receive general recommendations for physical activity (including strength and aerobic exercise) consistent with standard clinical advice, without supervised training or structured intervention. The study does not include randomization, control group, or experimental assignment, as it aims to evaluate adherence, acceptability, and tolerability of nutritional supplementation in a real-world setting.
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
Adherence to supplementation assessed as the percentage of prescribed doses consumed during the 12-week study period, based on participant self-reported daily supplementation logs. Adherence will be expressed as a continuous variable (0-100%). In addition, the proportion of participants achieving ≥80% adherence at Week 12 will be calculated. Higher values indicate greater adherence.
Time frame: 12 weeks
Proportion of Participants Persisting with Supplementation at Week 12
Persistence with supplementation defined as the proportion of participants who continue taking the supplement until the end of the study period (Week 12). Results will be expressed as the percentage of participants who remain on supplementation. Reasons for discontinuation will be recorded and summarized descriptively.
Time frame: 12 weeks
Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)
Participant-reported satisfaction assessed using a numeric rating scale from 0 to 10, where 0 indicates no satisfaction and 10 indicates maximum satisfaction. Willingness to continue supplementation is assessed using a binary (yes/no) question. Summary measures will include mean satisfaction scores and the proportion of participants willing to continue supplementation.
Time frame: 12 weeks
Number of Participants With Adverse Events Related or Unrelated to Supplementation
Number of participants reporting adverse events during the 12-week study period, including the type of event, severity, and investigator-assessed relationship to supplementation. Adverse events will be summarized by frequency and percentage of participants affected.
Time frame: 12 weeks
Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log)
Adherence to recommended physical activity assessed using a study-specific daily self-reported exercise log, in which participants record the performance (yes/no) of strength exercise (30 minutes), aerobic exercise (30 minutes), and stretching (5 minutes) on a daily basis. Adherence will be calculated as the proportion of days in which recommended activities are performed over the study period (0-100%), where higher values indicate greater adherence to physical activity recommendations.
Time frame: 12 weeks
Change in Handgrip Strength Measured by Dynamometry (kg)
Change in handgrip strength measured using a hand dynamometer (kg) between baseline and Week 12. Three consecutive measurements will be performed on the same hand, and the mean value (kg) will be calculated for each participant. Higher values indicate greater muscle strength.
Time frame: Baseline to Week 12
Change in Joint Pain Measured by Visual Analog Scale (VAS, 0-10)
Change in perceived joint pain measured using a Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates worst possible pain, between baseline and Week 12. Higher scores indicate greater pain.
Time frame: Baseline to Week 12
Change in Body Composition Measured by Bioimpedance Analysis (Lean Mass, Fat Mass, Total Body Water, Protein, Skeletal Muscle Mass)
Change in body composition parameters assessed by bioimpedance analysis between baseline and Week 12, including lean mass (kg), fat mass (kg), total body water (%), protein mass (kg), and skeletal muscle mass (kg). Changes in these parameters will be analyzed descriptively, with higher lean mass, protein mass, skeletal muscle mass, and total body water, and lower fat mass, indicating improved body composition.
Time frame: Baseline to Week 12
Change Cervantes Scale of Health-Related Quality of Life total score (0-40) and by domains
Change in quality of life assessed using the Cervantes Scale, a validated 31-item questionnaire specific for menopausal women. The questionnaire includes the following domains: menopause and health, psychological domain, sexuality, couple relationship, and vasomotor symptoms. Domain-specific scores and total score will be analyzed descriptively. Questionnaires with 3 or more missing items will be considered invalid; questionnaires with 1 or 2 missing items will be handled according to the correction rules specified in the instrument manual.
Time frame: Baseline to Week 12
Change in Skin Health Perception Measured by Visual Analog Scale (VAS, 0-10)
Change in perceived skin health assessed using a Visual Analog Scale (VAS; 0-10) evaluating multiple domains, including skin hydration and comfort, luminosity and overall appearance, anti-aging perception, and overall perceived efficacy. Each domain is scored from 0 to 10, where 0 indicates the worst perception and 10 indicates the best perception. Higher scores indicate better perceived skin health. Summary measures will include mean scores for each domain.
Time frame: Baseline to Week 12
Plan to share: No — The study was not designed with a formal data-sharing plan, and appropriate governance mechanisms for external data access have not been established.
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