What this trial studies
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with creatine HCl and creatine ethyl ester supplementation on cognitive performance, multidimensional fatigue, brain metabolism, and biochemical indices in perimenopausal and menopausal women
Conditions in scope
- Menopausal
- Perimenopause
Interventions
- Dietary Supplement: Experimental 1 Creatine HCl (Dietary Supplement) — Creatine hcl
- Dietary Supplement: Experimental 2 Creatine HCl (Dietary Supplement) — Creatine hcl
- Dietary Supplement: Experimental 3 Creatine Ethyl ester (Dietary Supplement) — Creatine ethyl ester
- Dietary Supplement: Experimental 4 Placebo (Dietary Supplement) — Placebo
Who can join
Women only · Ages 40 Years to 65 Years
Inclusion criteria
- Body mass index 18.5 - 29.9 kg/m2
- Free of major chronic diseases or acute disorders (including AD and dementia (MMSE score \> 25 points)
- MENOPAUSAL: no menstrual cycle for consecutive 12 months (with no other obvious causes)
- PERIMENOPAUSAL: Still menstruating (regular or irregular) but have at least one of the following symptoms: (1) hot flashes, (2) sleep disturbances, (3) mood swings, and (4) concentration difficulties
- Given written informed consent
Exclusion criteria
- History of dietary supplement use 4 weeks before the study commences
- Pregnancy (or planning pregnancy)
- Abnormal values for lab clinical chemistry (\> 2 SD)
- Unwillingness to return for follow-up analysis
- Participation in other clinical trials
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Novi Sad | Vojvodina | FSPE Applied BIoenergetcis Lab | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: N/A
- Start date: 2024-11-15
- Primary completion: 2025-05-15
- Last update posted: 2025-12-16
- First posted: 2024-10-26
Sponsor & contact
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Fatigue (Change from baseline fatigue at 8 weeks)
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06660004 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.