Womens HealthNCT07429071
Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.
A study testing Papilocare Vaginal Gel in people with Womens Health and Cervical Dysplasia, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN)
- What is being tested?
- Papilocare Vaginal Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- 9 Jun 2026to Dec 2026
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 30-50 years
- A positive hrHPV test with histopathological confirmed CIN1 or CIN2
- Managed under a 'watchful waiting' strategy as part of standard management
- Understand Danish, both written and orally
Who cannot join
- Pregnancy or breastfeeding
- Unexplained vaginal bleeding
- Immunosuppressive or immunomodulatory conditions or treatment
- Diabetes mellitus
- Prior hysterectomy
- Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital/anal region within 5 years (excl. non-melanoma skin cancer)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vibe M Bertelsen, Post.Doc, MD, Ph.D. contact
Denmark2 sites, 2 recruiting
- Recruiting
Department of Gynaecology and Obstetrics
Horsens, 8700
Mathilde K Kristensen, Medical student, 42199674, makrki@rm.dk
- Recruiting
Department of Gynaecology and Obstetrics
Randers
Mathilde Kristine Kristensen, Medical student, +4542199674, makrki@rm.dk
About this study
Official title: Effectiveness of Coriolus Versicolor-based Vaginal Gel on HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1/CIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome.
The primary outcomes therefore is:
Read more
- hrHPV clearance from baseline to follow-up (6 months)
In this randomized controlled study, eligible participants will be randomized 1:1 into two groups:
- Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).
- Control group; Women (n=35) will follow the conventional "wait and see" approach.
Read the detailed description
Persistent high-risk Human Papillomavirus (hrHPV) infections and Cervical Intraepithelial Neoplasia (CIN) represent significant public health and clinical concern. Currently, no established treatment is available to promote HPV clearance, and cervical excision remains the standard treatment for moderate- to high-grade CIN lesions despite its procedural risks. Management of women with mild to moderate lesions often involves "watchful waiting" with repeated controls, which may impose a considerable psychological burden. Therefore, there is a clinical need for effective, non-invasive treatment options for this patient population. To address this need, the primary aim of this study is to evaluate the effectiveness of a vaginal gel (Papilocare®) containing Coriolus Versicolor (CV) extract and other natural ingredients, in promoting hrHPV clearance. Secondary aims include evaluation of histological CIN regression, changes in vaginal microbiome composition, levels of stress and anxiety, patient satisfaction and treatment compliance.
This study is a multicenter, parallel-group, randomized controlled trial including women aged 30 to 50 years with both known hrHPV and histologically confirmed CIN1 or CIN2 (n = 70). Outcome assessors will be blinded to treatment allocation.
Participants will be randomized 1:1 to either six months of treatment with Papilocare® Vaginal gel (n = 35), or six months of conventional "watchful waiting" strategy (n = 35). Both groups will have a follow-up examination after 6 months, including colposcopy, cervical biopsies and two self-collected vaginal swabs for hrHPV genotyping and microbiome assessment. Participants will complete digital questionnaires before and after the intervention period, including the State-Trait Anxiety Inventory (STAI-20) and the Perceived Stress Scale (PSS-10). Additionally, the intervention group will complete questionnaires evaluating treatment compliance and satisfaction at 3 and 6 months.
This study will provide important evidence on effectiveness of a CV-based vaginal gel in women with hrHPV infection and CIN lesions. The inclusion of histopathological evaluation and comparison of vaginal microbiome composition will provide novel insight into biological factors associated with hrHPV clearance and CIN regression. If proven clinically effective, this intervention could offer a new, safe and non-surgical treatment option for women with hrHPV-related cervical lesions, addressing an unmet need where no approved therapeutic treatment currently exists.
Both positive, negative, and inconclusive results from the project will be published in international peer-reviewed scientific journals and presented at national as well as international conferences.
- Conditions
- Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Non-invasive Treatment, Human Papilloma Virus (HPV)
- Being tested
- Papilocare Vaginal Gel
- Keywords
- Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Human Papillomavirus (HPV), Non-Invasive Treatments
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papilocare Vaginal GelCombination product
Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Combination Product: Papilocare Vaginal Gel |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type specific HPV clearance
Additional HPV self-samples will be collected by the paticipants before initiation of the vaginal gel and after 6 months of treatment.
Measured: 6 months
Secondary outcomes (3)
Histopathologically CIN regression
CIN regression evaluated by cervical biopsies after 6 months
Measured: at baseline and after 6 months
Patient compliance and satisfaction measures
Compliance and treatment satisfaction will be assessed using patient-reported questionnaires and outcomes is measured using a 5-point Likert scale (minimum value = 1, maximum value = 5), where higher scores indicate a better outcome.
Measured: 6 months
Characterizing the Vaginal Microbiome
A self-collected vaginal swab will be obtained before treatment initiation and again after six months of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start9 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Womens HealthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Procare Health Iberia S.L.
- Responsible party
- Principal investigator, Vibe Munk Bertelsen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429071
- Sponsor's protocol ID
- 16-0302-44
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Coriolus Versicolor-based Vaginal Gel on HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07429071
- Acronym / sponsor ID
- 16-0302-44
- Conditions
- Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Non-invasive Treatment, Human Papilloma Virus (HPV)
- Keywords
- Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Human Papillomavirus (HPV), Non-Invasive Treatments
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Procare Health Iberia S.L.
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Feb 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.
The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1/CIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome.
The primary outcomes therefore is:
- hrHPV clearance from baseline to follow-up (6 months)
In this randomized controlled study, eligible participants will be randomized 1:1 into two groups:
- Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).
- Control group; Women (n=35) will follow the conventional "wait and see" approach.
Detailed description
Persistent high-risk Human Papillomavirus (hrHPV) infections and Cervical Intraepithelial Neoplasia (CIN) represent significant public health and clinical concern. Currently, no established treatment is available to promote HPV clearance, and cervical excision remains the standard treatment for moderate- to high-grade CIN lesions despite its procedural risks. Management of women with mild to moderate lesions often involves "watchful waiting" with repeated controls, which may impose a considerable psychological burden. Therefore, there is a clinical need for effective, non-invasive treatment options for this patient population. To address this need, the primary aim of this study is to evaluate the effectiveness of a vaginal gel (Papilocare®) containing Coriolus Versicolor (CV) extract and other natural ingredients, in promoting hrHPV clearance. Secondary aims include evaluation of histological CIN regression, changes in vaginal microbiome composition, levels of stress and anxiety, patient satisfaction and treatment compliance.
This study is a multicenter, parallel-group, randomized controlled trial including women aged 30 to 50 years with both known hrHPV and histologically confirmed CIN1 or CIN2 (n = 70). Outcome assessors will be blinded to treatment allocation.
Participants will be randomized 1:1 to either six months of treatment with Papilocare® Vaginal gel (n = 35), or six months of conventional "watchful waiting" strategy (n = 35). Both groups will have a follow-up examination after 6 months, including colposcopy, cervical biopsies and two self-collected vaginal swabs for hrHPV genotyping and microbiome assessment. Participants will complete digital questionnaires before and after the intervention period, including the State-Trait Anxiety Inventory (STAI-20) and the Perceived Stress Scale (PSS-10). Additionally, the intervention group will complete questionnaires evaluating treatment compliance and satisfaction at 3 and 6 months.
This study will provide important evidence on effectiveness of a CV-based vaginal gel in women with hrHPV infection and CIN lesions. The inclusion of histopathological evaluation and comparison of vaginal microbiome composition will provide novel insight into biological factors associated with hrHPV clearance and CIN regression. If proven clinically effective, this intervention could offer a new, safe and non-surgical treatment option for women with hrHPV-related cervical lesions, addressing an unmet need where no approved therapeutic treatment currently exists.
Both positive, negative, and inconclusive results from the project will be published in international peer-reviewed scientific journals and presented at national as well as international conferences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Papilocare Vaginal Gel |
| Control | No intervention | – |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 30-50 years
- A positive hrHPV test with histopathological confirmed CIN1 or CIN2
- Managed under a 'watchful waiting' strategy as part of standard management
- Understand Danish, both written and orally
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Unexplained vaginal bleeding
- Immunosuppressive or immunomodulatory conditions or treatment
- Diabetes mellitus
- Prior hysterectomy
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 |
|---|---|---|
| Papilocare Vaginal GelWomen (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle). | Combination product | Intervention |
Primary outcome
Type specific HPV clearance
Time frame: 6 months
Additional HPV self-samples will be collected by the paticipants before initiation of the vaginal gel and after 6 months of treatment.
3 secondary outcomes
Histopathologically CIN regression
Time frame: at baseline and after 6 months
Patient compliance and satisfaction measures
Time frame: 6 months
Characterizing the Vaginal Microbiome
Time frame: 6 months
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Vibe M Bertelsen, Post.Doc, MD, Ph.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papilocare Vaginal Gel in people with Womens Health and Cervical Dysplasia, run by University of Aarhus 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 4 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: looking for participants now, as of the sponsor's last update on 3 Aug 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 Pinar Bor, Professor, MD, Ph.D. (22504767, isipinbo@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type specific HPV clearance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.