An interventional study of HerAccess integrated care pathway in Vestibulodynia, Vulvodynia and Vulvar Vestibulitis, sponsored by HerAccess ApS. Not yet recruiting at 2 sites in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by HerAccess ApS · Not applicable, Interventional, and Health services research
This single-arm pilot study evaluates whether an integrated six-month care pathway for women with persistent vestibular vulvar pain and suspected hormonally mediated vestibulodynia can be delivered as planned, and how participants and clinicians experience it.
The pathway brings existing clinical and supportive elements together in one coordinated sequence: a digital symptom questionnaire whose answers are organised by topic for clinician review, specialist pre-screening by a gynaecologist with expertise in vulvar pain, pelvic floor screening by an authorised pelvic floor physiotherapist, gynaecological assessment by the responsible investigator, individual clinical management, pharmacy coordination, optional home videos and psychosexual support, and follow-up.
Up to 35 women aged 18-45 in Denmark are followed for 24 weeks. The study measures pathway feasibility (consent, completion of pathway steps, handover times, retention, deviations) and acceptability (participant and clinician experience). It does not measure symptom change or treatment effect.
Background. Women with persistent vestibular vulvar pain in Denmark are commonly assessed and treated across separate services without a coordinating structure. It is not known whether the individual clinical and supportive elements can be delivered as one continuous pathway, or whether participants and clinicians find such a pathway workable. This pilot provides that knowledge before any larger evaluation is designed.
Hypotheses. H1 (feasibility): the core pathway steps can be delivered as planned for the majority of enrolled participants, with handovers completed within the intended intervals and retention at week 24 sufficient to support a larger study. H2 (acceptability): participants and clinicians rate the pathway as clear, coordinated and manageable, and a majority of participants would choose or recommend a similar pathway. Both are assessed against pre-specified traffic-light progression criteria (green/amber/red).
Recruitment and eligibility phase. Candidates are contacted from an existing waitlist and, if needed, through committee-approved recruitment material. Candidates complete a structured digital symptom questionnaire. The questionnaire performs no scoring or classification; it presents the participant's own answers by topic for clinician review. A gynaecologist with specialist expertise in vulvar pain reviews the questionnaire and treatment history and decides, on her own clinical judgement, whether the candidate proceeds. This pre-screening decision is not a diagnosis.
Consent. Candidates who proceed receive written participant information and a separate oral information conversation, followed by at least 24 hours' reflection. Written consent is signed digitally or on paper before any examination. Enrolment begins with written consent.
Clinical pathway. After consent: focused pelvic floor screening for predominant hypertonic pelvic floor dysfunction by an authorised physiotherapist (screening only, no study treatment); gynaecological and vestibular examination and an individual care plan by the responsible investigator. The care plan may include topical treatment, other clinical recommendations, further investigation or referral. Where clinically indicated, the responsible investigator may prescribe a named-patient compounded topical estradiol 0.01% / testosterone 0.1% preparation, dispensed by a compounding pharmacy. Treatment is ordinary clinical practice decided for the individual participant and is not the object of study. Participants may also use optional gentle movement and pelvic floor relaxation videos and a consultation with a clinical sexologist.
Research data. Pathway process records, patient-reported experience questionnaires (after the first consultation, week 12 and week 24), clinician workflow feedback and a qualitative interview at about week 24. Clinical findings, examination results, pain ratings, prescriptions and adverse reactions are documented in the patient record by the treating clinicians and are not collected as research data.
Analysis. Descriptive. Proportions with counts, denominators and 95% confidence intervals; time intervals as medians with ranges; experience data as distributions and medians; free-text and interview material analysed thematically. Sample size (up to 35) is justified on precision and observation grounds; no power calculation is performed, as there is no comparative hypothesis.
Limitations. Single-arm, non-randomised design; self-selected waitlist population; sponsor-funded service and sponsor commercial interest; qualitative coding by a single coder. Results will be published irrespective of direction.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's planned enrollment of 35 is below the median of 46 across 89 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →This is the only study on the registry with HerAccess ApS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants follow a 24-week coordinated pathway: digital symptom questionnaire for clinician review, specialist pre-screening, pelvic floor screening, gynaecological assessment and individual care plan by the responsible investigator, individual clinical management (which may include a clinician-prescribed compounded topical estradiol/testosterone preparation where clinically indicated), pharmacy coordination, optional home videos and psychosexual support, and experience follow-up at weeks 12 and 24.
Other: HerAccess integrated care pathway
Coordination of existing clinical and supportive elements into one pathway: (1) digital symptom questionnaire presenting the participant's own answers by topic for clinician review, with no scoring or classification; (2) specialist pre-screening by a gynaecologist with vulvar pain expertise; (3) pelvic floor screening by an authorised pelvic floor physiotherapist; (4) gynaecological and vestibular examination and individual care plan by the responsible investigator; (5) individual clinical management decided by the responsible investigator, which may include a named-patient compounded topical estradiol 0.01%/testosterone 0.1% preparation where clinically indicated; (6) pharmacy coordination; (7) optional movement and pelvic floor relaxation videos; (8) optional clinical sexologist consultation; (9) experience questionnaires and a final interview. The object of study is the delivery and experience of the pathway, not the effect of any individual treatment.
Recruitment
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).
Time frame: Up to 3 months from study start
Retention at 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)
Time frame: Week 24
Completion of core pathway steps
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)
Time frame: From enrolment through week 24
Handovers within target intervals
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).
Time frame: From questionnaire completion through week 24
Participant-rated clarity, coordination and manageability
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)
Time frame: Week 12 and week 24
Clinician-rated workflow usability
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)
Time frame: End of study (after the last participant's week-24 follow-up)
Willingness to choose or recommend the pathway
Proportion of participants who would choose or recommend a similar pathway. Pre-specified progression threshold: at least 70% (green)
Time frame: Week 24
Protocol deviations and failed handovers
Number and type of protocol deviations, failed handovers and unresolved operational issues.
Time frame: From enrolment through week 24
Participant experience ratings
Distribution of participant ratings for feeling heard, continuity, knowing who to contact, support and practical burden.
Time frame: Week 12 and week 24
Uptake of optional supportive components
Number and proportion of participants using the optional videos and psychosexual support, and their perceived relevance.
Time frame: Through week 24
Themes in participant and clinician experience
Thematic analysis of free-text responses and the week-24 participant interview, focusing on coordination, continuity, burden, support and implementation.
Time frame: Week 24
Plan to share: No — Individual participant data will not be shared. With a small sample (up to 35 participants) and sensitive sexual-health information, the risk of re-identification is high, and participants have not consented to data sharing. Results are published in anonymised and aggregated form only, in line with the study's approved data protection model; qualitative findings are presented only as anonymised paraphrases or quotations after a documented anonymisation assessment.
Start is estimated for Jan 2027; primary completion for Sep 2027, 8 months later.
Of 32 interventional studies with no phase under Vulvodynia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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