Development and Validation of the CervantesPROM, a New Menopause-Specific Quality-of-Life Measure
NCT07932834, Not yet recruiting, Asociación Española para el Estudio de la Menopausia
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Development and Validation of the CervantesPROM, a New Menopause-Specific Quality-of-Life Measure | ClinicalTrials.gov |
| NCT number | NCT07932834 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 950 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Asociación Española para el Estudio de la Menopausia | ClinicalTrials.gov |
| Conditions | Menopause, Perimenopause, Postmenopause, Climacteric Women, Quality of Life | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of CervantesPROM symptom items retained after item reduction | Single questionnaire administration at enrollment (Phase 2A). | The number of symptom items retained in the reduced CervantesPROM after applying the prespecified sequential psychometric item-reduction procedure to the 25 items of version 1.0. The outcome is reported as a single integer representing the final number of retained items (possible range: 0-25). | ClinicalTrials.gov |
| Primary | Comparative Fit Index (CFI) of the reduced CervantesPROM | Single questionnaire administration at enrollment (Phase 2B). | CFI obtained from confirmatory factor analysis of the prespecified factor structure. Higher values indicate better model fit. | ClinicalTrials.gov |
| Primary | Tucker-Lewis Index (TLI) of the reduced CervantesPROM | Single questionnaire administration at enrollment (Phase 2B). | TLI obtained from confirmatory factor analysis of the prespecified factor structure. Higher values indicate better model fit. | ClinicalTrials.gov |
| Primary | Root Mean Square Error of Approximation (RMSEA) of the reduced CervantesPROM | Single questionnaire administration at enrollment (Phase 2B). | RMSEA obtained from confirmatory factor analysis of the prespecified factor structure. Lower values indicate better model fit. | ClinicalTrials.gov |
| Primary | Standardized Root Mean Square Residual (SRMR) of the reduced CervantesPROM | Single questionnaire administration at enrollment (Phase 2B). | SRMR obtained from confirmatory factor analysis of the prespecified factor structure. Lower values indicate better model fit. | ClinicalTrials.gov |
| Primary | Cronbach's alpha of the reduced CervantesPROM total score | Single questionnaire administration at enrollment (Phase 2B). | Cronbach's alpha coefficient calculated to assess the internal consistency of the reduced CervantesPROM total score. | ClinicalTrials.gov |
| Primary | McDonald's omega of the reduced CervantesPROM total score | Single questionnaire administration at enrollment (Phase 2B). | McDonald's omega coefficient calculated to assess the internal consistency of the reduced CervantesPROM total score. | ClinicalTrials.gov |
| Secondary | Percentage of cognitive interview item assessments indicating comprehension difficulties | One optional interview of about 30 minutes, within 2 weeks after completing the questionnaire (Phase 2A) | The percentage of item-level assessments rated as "some difficulty" or "not understood" during structured cognitive interviews. Each participant evaluates 2-3 CervantesPROM items. The percentage ranges from 0% to 100%, with higher values indicating more comprehension difficulties (worse comprehensibility). This is a categorical assessment, not a questionnaire scale score. Verbal probing of all 25 items in 10-12 women (two rounds; at least 7 women per item): comprehension, distinction between bother and symptom intensity, response options, recall period and instructions. Comprehension problems are recorded per item and classified independently by two researchers. | ClinicalTrials.gov |
| Secondary | Test-retest reliability and measurement error | Baseline and 7 to 14 days (Phase 2B) | Intraclass correlation coefficient and standard error of measurement between two administrations of the CervantesPROM in stable postmenopausal participants. | ClinicalTrials.gov |
| Secondary | Percentage of prespecified construct validity hypotheses confirmed | Single questionnaire administration at enrollment (Phase 2B). | Percentage of prespecified construct validity hypotheses supported by the observed correlations between the reduced CervantesPROM and reference measures of menopausal symptoms, general health, mood and sexual function. Each hypothesis is evaluated against its prespecified direction and magnitude. The outcome ranges from 0% to 100%, with higher percentages indicating stronger evidence of construct validity. Construct validity is considered adequate when at least 75% of the hypotheses are confirmed. | ClinicalTrials.gov |
| Secondary | Standardized Response Mean (SRM) of the CervantesPROM total score | Baseline and 3 months (Phase 3). | SRM calculated as the mean change in the CervantesPROM total score from baseline to 3 months divided by the standard deviation of individual change scores. CervantesPROM scores range from 0 to 100, with higher scores indicating greater symptom-related burden. | ClinicalTrials.gov |
| Secondary | Work productivity loss associated with menopausal symptoms | Monthly for 3 months (Phase 3) | Days of absenteeism, presenteeism and interference with non-work activities recorded monthly by employed participants. | ClinicalTrials.gov |
| Secondary | Anchor-based minimal important difference (MID) in the CervantesPROM total score | Baseline and 3 months (Phase 3). | Minimal important difference in the CervantesPROM total score estimated using the Global Rating of Change scale at 3 months as an external anchor. The estimate will be expressed in CervantesPROM score points on a 0-100 scale. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)