VestibulodyniaHerAccessNCT07908901
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
A study testing HerAccess integrated care pathway in people with Vestibulodynia and Vulvodynia, run by HerAccess ApS at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vestibulodynia, Vulvodynia, Vulvar Vestibulitis
- What is being tested?
- HerAccess integrated care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Resident in Denmark throughout the 24-week follow-up period
- Provoked, unprovoked or mixed vestibular vulvar pain for at least three months
- Able to participate in Danish or English
- Able to attend the required clinical assessments in Copenhagen
- Able to provide informed consent and complete the study questionnaires
- Symptom history considered relevant, at specialist clinical pre-screening, for assessment within the pathway
Who cannot join
- Pregnancy or breastfeeding where the responsible investigator considers participation clinically inappropriate
- Active infection, unexplained bleeding, suspected malignancy or another condition requiring assessment outside the pathway
- A clinical condition that makes the planned examination unsafe or inappropriate
- Predominant hypertonic pelvic floor dysfunction, absence of an indicated hormonal component at specialist review, or another mechanism requiring a different principal care pathway (these participants receive guidance on appropriate next steps)
- Concurrent participation in another study that conflicts with the pathway
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
OsteoMedica
Copenhagen, Nørrebro, 2200
Deborah Tassi, info@osteomedica.dk
Klinik Hormony
Frederiksberg, 2000
Mie-Louise Larsen, MD, +45 30 22 71 06, info@klinikhormony.dk
Mie-Louise Larsen, MD
About this study
Official title: HerAccess Pilot Study: Feasibility and Acceptability of an Integrated Care Pathway for Hormonally Mediated Vestibulodynia
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.
Read the detailed description
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.
- Conditions
- Vestibulodynia, Vulvodynia, Vulvar Vestibulitis
- Being tested
- HerAccess integrated care pathway
- Keywords
- Hormonally Mediated Vestibulodynia, Vulvar Pain, Care Pathway, Integrated Care, Feasibility Study, Patient-Reported Experience, Health Services Research, Pelvic Floor
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerAccess integrated care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated care pathway | Other | 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. Receives: Other: HerAccess integrated care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Week 24
Secondary outcomes (3)
Protocol deviations and failed handovers
Number and type of protocol deviations, failed handovers and unresolved operational issues.
Measured: From enrolment through week 24
Participant experience ratings
Distribution of participant ratings for feeling heard, continuity, knowing who to contact, support and practical burden.
Measured: 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.
Measured: Through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VestibulodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants follow the same integrated care pathway over 24 weeks; individual clinical management is decided by the responsible investigator.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HerAccess ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinik Hormony
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908901
- Sponsor's protocol ID
- HERACCESS-HMV-PILOT-01
- Other IDs
- H-26073267
- Acronym
- HerAccess
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.
PubMed 27045258Goldstein AT, Burrows LJ, Goldstein SW. Can vestibulodynia be caused by hormonal contraception? J Sex Med. 2014;11(12):3008-3013.
Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD), the International Society for the Study of Women's Sexual Health (ISSWSH), and the International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. Obstet Gynecol. 2016 Apr;127(4):745-751. doi: 10.1097/AOG.0000000000001359.
PubMed 27008217Burrows LJ, Goldstein AT. The treatment of vestibulodynia with topical estradiol and testosterone. Sex Med. 2013 Aug;1(1):30-3. doi: 10.1002/sm2.4.
PubMed 25356284
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HerAccess Pilot Study: Feasibility and Acceptability of an Integrated Care Pathway for Hormonally Mediated Vestibulodynia
- ClinicalTrials.gov ID
- NCT07908901
- Acronym / sponsor ID
- HerAccess / HERACCESS-HMV-PILOT-01
- Conditions
- Vestibulodynia, Vulvodynia, Vulvar Vestibulitis
- Keywords
- Hormonally Mediated Vestibulodynia, Vulvar Pain, Care Pathway, Integrated Care, Feasibility Study, Patient-Reported Experience, Health Services Research, Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- HerAccess ApSIndustry (pharma, biotech, devices)
- Collaborators
- Klinik Hormony
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants follow the same integrated care pathway over 24 weeks; individual clinical management is decided by the responsible investigator.
| Arm | Type | Receives |
|---|---|---|
| Integrated care pathway | Other | Other: HerAccess integrated care pathwayParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-45 years
- Resident in Denmark throughout the 24-week follow-up period
- Provoked, unprovoked or mixed vestibular vulvar pain for at least three months
- Able to participate in Danish or English
- Able to attend the required clinical assessments in Copenhagen
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding where the responsible investigator considers participation clinically inappropriate
- Active infection, unexplained bleeding, suspected malignancy or another condition requiring assessment outside the pathway
- A clinical condition that makes the planned examination unsafe or inappropriate
- Predominant hypertonic pelvic floor dysfunction, absence of an indicated hormonal component at specialist review, or another mechanism requiring a different principal care pathway (these participants receive guidance on appropriate next steps)
- Concurrent participation in another study that conflicts with the pathway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HerAccess integrated care pathwayCoordination 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. | Other | Integrated care pathway |
Primary outcome
Recruitment
Time frame: 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).
Retention at week 24
Time frame: 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)
Completion of core pathway steps
Time frame: 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)
Handovers within target intervals
Time frame: 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).
Participant-rated clarity, coordination and manageability
Time frame: 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)
Clinician-rated workflow usability
Time frame: 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)
Willingness to choose or recommend the pathway
Time frame: Week 24
Proportion of participants who would choose or recommend a similar pathway. Pre-specified progression threshold: at least 70% (green)
3 secondary outcomes
Protocol deviations and failed handovers
Time frame: From enrolment through week 24
Participant experience ratings
Time frame: Week 12 and week 24
Uptake of optional supportive components
Time frame: Through week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 27045258Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.
- BackgroundGoldstein AT, Burrows LJ, Goldstein SW. Can vestibulodynia be caused by hormonal contraception? J Sex Med. 2014;11(12):3008-3013.
- Background: PubMed 27008217Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD), the International Society for the Study of Women's Sexual Health (ISSWSH), and the International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. Obstet Gynecol. 2016 Apr;127(4):745-751. doi: 10.1097/AOG.0000000000001359.
- Background: PubMed 25356284Burrows LJ, Goldstein AT. The treatment of vestibulodynia with topical estradiol and testosterone. Sex Med. 2013 Aug;1(1):30-3. doi: 10.1002/sm2.4.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HerAccess integrated care pathway in people with Vestibulodynia and Vulvodynia, run by HerAccess ApS at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Jolak (+4553611929, stefanie@heraccess.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Up to 3 months from study start). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07908901, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.