What is this study trying to find out about menopause and estrogen deficiency?

This study aims to understand how well estrogen-depleted women follow a creatine-based nutritional supplement routine and physical activity recommendations. It focuses on adherence, satisfaction, and tolerability of the supplement in real-life conditions. The sponsor, Margan Biotech, seeks to gather information that may help guide future research and care for this group.

Who may be eligible for this menopause clinical trial?

Women aged 40 to 75 years who are estrogen-depleted due to menopause or late perimenopause may be eligible. Participants must be able to take the supplement and follow physical activity advice, have no major health issues that would prevent this, and be willing to attend study visits. The study includes only females. Please review eligibility criteria for more details.

Is there any cost to participate in this menopause clinical trial?

Study-related care, including the nutritional supplement and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs associated with participation.

Actively Recruiting

Age: 40Years - 75Years

FEMALE

Healthy Volunteers

ID07580846

Study of Adherence to Creatine-Based Nutritional Supplement in Estrogen-Depleted Women Aged 40 to 75

Led by Margan Biotech · Updated on 2026-05-12

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study to understand how well estrogen-depleted adult women, including those in menopause or late perimenopause, adhere to a creatine-based nutritional supplement called Creaticare FEM. The study aims to describe the percentage of doses consumed and the proportion of women achieving high adherence 80% or more over 12 weeks. It also looks at persistence, satisfaction, tolerability, and adherence to physical activity recommendations, along with exploratory measures like muscle strength, body composition, quality of life, joint pain, and skin health. Participants will take a daily 10-gram dose of Creaticare FEM, which contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins A, C, E, and B6, for 12 weeks. Alongside supplementation, they receive general physical activity advice consistent with usual clinical care, without supervised exercise or randomization. The study is observational and does not include control groups or experimental interventions beyond routine supplementation. During the 12-week period, women will attend planned visits and complete various assessments, including self-reported adherence to the supplement and physical activity, adverse event monitoring, and questionnaires on satisfaction. Exploratory assessments will measure changes in muscle strength, body composition, quality of life, joint pain, and skin health. The study seeks to provide real-world information on how well this nutritional supplement is accepted and tolerated in this population.

CONDITIONS

Brief Title

ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women

Who Can Participate

Age: 40Years - 75Years

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Biological female sex.
Age 40 years or older.
Estrogen-depleted status, including natural menopause (no menstrual periods for 12 months), surgically induced menopause, or late perimenopause with elevated FSH.
No major health problems that prevent use of the supplement or physical activity.
No significant changes in usual treatments in the past 3 months.
Ability to understand study information and provide written consent.
Willingness to take the supplement as instructed.
Willingness to follow general physical activity recommendations.
Willingness and ability to attend visits and complete assessments through 12 weeks.

You will not qualify if you...

Starting or changing treatment with GLP-1 receptor agonists in the last 12 weeks.
Musculoskeletal or joint conditions that limit regular physical activity or study assessments.
Significant kidney or liver disease.
Current use of diuretics or medications harmful to kidneys.
Known allergy or intolerance to any supplement ingredient.
Participation in another clinical study in the last 3 months.
Any medical or social condition that could interfere with participation, adherence, or data validity.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 weeks

Participants take a daily creatine-based nutritional supplement for 12 weeks and follow general physical activity recommendations as part of routine care. Adherence, acceptability, and tolerability of the supplementation are observed during this period.

Visits as needed for assessments during the 12-week supplementation period