Trial · NCT07908901
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
NCT07908901, Not applicable, Not yet recruiting, HerAccess ApS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot. Trials, record NCT07908901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
- NCT number
- NCT07908901
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 35 participants, estimated
- Lead sponsor
- HerAccess ApS
- Conditions
- Vestibulodynia, Vulvodynia, Vulvar Vestibulitis
- Interventions
- HerAccess integrated care pathway
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment | Up to 3 months from study start | Description: Proportion of the target sample (35) enrolled within 3 months of study start, and the proportion of contacted candidates who provide written consent. Pre-specified progression threshold: at least 80% of target (green). |
| Primary | Retention at week 24 | Week 24 | Proportion of enrolled participants retained at week 24, with reasons for withdrawal or non-progression. Pre-specified progression threshold: at least 75% (green) |
| Primary | Completion of core pathway steps | From enrolment through week 24 | Proportion of enrolled participants completing each core pathway step (pelvic floor screening, gynaecological assessment, documented care plan, pharmacy handover where relevant) and the week-12 and week-24 follow-up. Pre-specified progression threshold: at least 80% (green) |
| Primary | Handovers within target intervals | From questionnaire completion through week 24 | Time in working days between principal pathway steps (questionnaire to pre-screening; pre-screening to pelvic floor screening; pelvic floor screening to gynaecological consultation; prescription to delivery), reported as medians with ranges, and the proportion of handovers completed within target intervals. Pre-specified progression threshold: at least 80% (green). |
| Primary | Participant-rated clarity, coordination and manageability | Week 12 and week 24 | Proportion of participants giving top-2 responses on the study's experience questionnaire items for clarity, coordination and manageability of the pathway. Pre-specified progression threshold: at least 75% (green) |
| Primary | Clinician-rated workflow usability | End of study (after the last participant's week-24 follow-up) | Clinician ratings of the organisation, completeness and usability of the structured symptom report and pathway processes. Pre-specified progression threshold: a clear majority of clinicians rate the workflow usable (green) |
| Primary | Willingness to choose or recommend the pathway | Week 24 | Proportion of participants who would choose or recommend a similar pathway. Pre-specified progression threshold: at least 70% (green) |
| Secondary | Protocol deviations and failed handovers | From enrolment through week 24 | Number and type of protocol deviations, failed handovers and unresolved operational issues. |
| Secondary | Participant experience ratings | Week 12 and week 24 | Distribution of participant ratings for feeling heard, continuity, knowing who to contact, support and practical burden. |
| Secondary | Uptake of optional supportive components | Through week 24 | Number and proportion of participants using the optional videos and psychosexual support, and their perceived relevance. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908901
GET https://conductscience.org/api/trials/v1/NCT07908901/registered