Trial · NCT07904390
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the psychological subscale score of the Menopause Rating Scale (MRS) | Baseline (visit 1) and week 12 (visit 3) | The MRS psychological subscale is the sum of items 4 to 7 (depressive mood, irritability, anxiety, and physical and mental exhaustion), each rated from 0 (none) to 4 (very severe). Score range 0 to 16; higher scores indicate greater symptom severity. Change is the week 12 score minus the baseline score. |
| Secondary | Change in total MRS score | Baseline, week 6 and week 12 | Sum of the 11 MRS items, each rated 0 to 4. Score range 0 to 44; higher scores indicate greater severity. |
| Secondary | Change in MRS somatic-vegetative subscale score | Baseline, week 6 and week 12 | Sum of items 1, 2, 3 and 11. Score range 0 to 16; higher scores indicate greater severity. |
| Secondary | Change in MRS urogenital subscale score | Baseline, week 6 and week 12 | Sum of items 8, 9 and 10. Score range 0 to 12; higher scores indicate greater severity. |
| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) score | Baseline and week 12 (optional at week 6) | Seven items rated 0 to 3. Score range 0 to 21; higher scores indicate more anxiety symptoms. |
| Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) score | Baseline and week 12 (optional at week 6) | Nine items rated 0 to 3. Score range 0 to 27; higher scores indicate more depressive symptoms. |
| Secondary | Change in the Cervantes Scale global score | Baseline and week 12 | The Cervantes Scale is a 31-item, menopause-specific health-related quality of life questionnaire. Each item is rated from 0 to 5. The global score ranges from 0 to 155; higher scores indicate worse health-related quality of life. Change is the week 12 score minus the baseline score. |
| Secondary | Change in the Cervantes Scale sexuality domain score | Baseline and week 12 | The sexuality domain of the Cervantes Scale (31-item, menopause-specific health-related quality of life questionnaire) comprises 4 items on sexual function, each rated from 0 to 5. The domain score ranges from 0 to 20; higher scores indicate worse sexual function. Change is the week 12 score minus the baseline score. |
| Secondary | Change in body fat percentage | Baseline and week 12 | Body fat percentage measured by bioimpedance. |
| Secondary | Change in estimated visceral fat | Baseline and week 12 | Visceral fat estimate measured by bioimpedance. |
| Secondary | Change in hot flash intensity (visual analogue scale) | Baseline, week 6 and week 12 | 0-10 scale; 0 = no hot flashes, 10 = maximum imaginable intensity. |
| Secondary | Change in sleep quality (visual analogue scale) | Baseline, week 6 and week 12 | 0-10 scale; 0 = very poor sleep quality, 10 = excellent sleep quality. |
| Secondary | Change in mood (visual analogue scale) | Baseline, week 6 and week 12 | 0-10 scale; 0 = very poor mood, 10 = excellent mood. |
| Secondary | Number of participants with adverse events | From baseline to week 12 | Incidence, nature, severity, duration and relationship to the intervention, including events that lead to interruption of the intervention or withdrawal. |
| Secondary | Change in liver profile | Baseline and week 12 | Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase and bilirubin. |
| Secondary | Change in lean mass | Baseline and week 12 | Lean mass in kilograms measured by bioimpedance. |
| Other | Change in lipid profile | Baseline and week 12 | Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides. |
| Other | Change in serum estradiol | Baseline and week 12 | Serum estradiol concentration. |
| Other | Change in serum follicle-stimulating hormone (FSH) | Baseline and week 12 | Serum FSH concentration. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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