Human Papillomavirus InfectionDUAL-HPVNCT07735039
Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
A study testing Oral Immunomodulator, Vaginal Ovule and Standard Supportive Care in people with Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia (CIN), run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia (CIN), Low-Grade Squamous Intraepithelial Lesions
- What is being tested?
- Oral Immunomodulator, Vaginal Ovule and Standard Supportive Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2026to 24 Aug 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years.
- Confirmed persistent high-risk human papillomavirus (HR-HPV) infection.
- Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL.
- Eligible for conservative follow-up without immediate excisional treatment.
- Ability to provide written informed consent and comply with study procedures.
Who cannot join
- HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer.
- Pregnancy or breastfeeding.
- Immunodeficiency or current immunosuppressive therapy.
- Previous treatment for cervical dysplasia within the last 6 months.
- Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period.
- Known hypersensitivity to any study intervention.
- Participation in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul, 34865
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of a Dual-Modality Immunotherapy (Oral Immunomodulator and Vaginal Ovule) for Human Papillomavirus (HPV) Clearance
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
Read the detailed description
Persistent high-risk human papillomavirus infection is a major risk factor for cervical intraepithelial neoplasia and cervical cancer. Although many infections regress spontaneously, persistent infection may require close surveillance, and non-invasive therapeutic strategies that may enhance host immune response and promote viral clearance remain clinically relevant.
This is a prospective, single-center, randomized, assessor-blinded, parallel-group controlled trial conducted at the Department of Gynecologic Oncology of Kartal Dr. Lutfi Kirdar City Hospital.
A total of 76 participants will be randomized in a 1:1 ratio using a computer-generated allocation sequence, with 38 participants assigned to each group. Treatment allocation will be managed by an unblinded study team member. Outcome assessors will remain blinded to group assignment.
Participants in the intervention arm will receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months. Participants in the control arm will receive standard supportive care.
Eligible participants must have confirmed HPV positivity with low-grade cervical abnormalities, including ASC-US, LSIL, or CIN 1, and must not require an invasive cervical procedure such as biopsy, colposcopy-directed treatment, or LEEP during the 3-month study period.
The primary endpoint is HPV clearance at the end of 3 months, confirmed by repeat HPV testing and cervical cytology. Participants will be monitored monthly for treatment adherence and adverse events.
The planned sample size is 76 participants, with 38 participants per group, based on a two-sided alpha level of 0.05 and 80% statistical power.
The study was approved by the Kartal Dr. Lutfi Kirdar City Hospital Scientific Research Ethics Committee (Approval No. 2026/010.99/26/46).
- Conditions
- Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia (CIN), Low-Grade Squamous Intraepithelial Lesions
- Being tested
- Oral Immunomodulator, Vaginal Ovule, Standard Supportive Care
- Keywords
- High-risk HPV, HPV Clearance, Human Papillomavirus, İmmunomodulator, Vaginal Ovule, Cervical Dysplasia, ASC-US, LSIL, CIN1, Randomized Controlled Trial
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ImmunomodulatorDrug
Oral immunomodulator administered twice daily for 3 months.
Vaginal OvuleDrug
Vaginal ovule administered for 14 consecutive days each month for 3 months.
Standard Supportive CareOther
Standard supportive care according to routine clinical practice during the 3-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Modality Immunotherapy | Experimental | Participants receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months. Receives: Drug: Oral Immunomodulator; Drug: Vaginal Ovule |
| Standard Supportive Care | Active comparator | Participants receive standard supportive care for 3 months according to routine clinical practice. Receives: Other: Standard Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV clearance rate
The proportion of participants with a negative high-risk HPV test at the end of the 3-month treatment period.
Measured: 3 months
Secondary outcomes (1)
Cytological regression
Proportion of participants demonstrating regression of cervical cytology after treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start28 Apr 2026
- Primary completion23 Aug 2026 (estimated)
- Study completion24 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either dual-modality immunotherapy or standard supportive care and followed in parallel for three months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özge Nur Gülen, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735039
- Sponsor's protocol ID
- 2026/010.99/26/46
- Acronym
- DUAL-HPV
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not yet been determined. Data sharing may be considered after study completion upon reasonable request, subject to institutional policies, ethics committee approval, and applicable confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of a Dual-Modality Immunotherapy (Oral Immunomodulator and Vaginal Ovule) for Human Papillomavirus (HPV) Clearance
- ClinicalTrials.gov ID
- NCT07735039
- Acronym / sponsor ID
- DUAL-HPV / 2026/010.99/26/46
- Conditions
- Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia (CIN), Low-Grade Squamous Intraepithelial Lesions
- Keywords
- High-risk HPV, HPV Clearance, Human Papillomavirus, İmmunomodulator, Vaginal Ovule, Cervical Dysplasia, ASC-US, LSIL
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 23 Aug 2026 (estimated)
- Study completion
- 24 Aug 2026 (estimated)
- First posted
- 29 Jul 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.
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
Detailed description
Persistent high-risk human papillomavirus infection is a major risk factor for cervical intraepithelial neoplasia and cervical cancer. Although many infections regress spontaneously, persistent infection may require close surveillance, and non-invasive therapeutic strategies that may enhance host immune response and promote viral clearance remain clinically relevant.
This is a prospective, single-center, randomized, assessor-blinded, parallel-group controlled trial conducted at the Department of Gynecologic Oncology of Kartal Dr. Lutfi Kirdar City Hospital.
A total of 76 participants will be randomized in a 1:1 ratio using a computer-generated allocation sequence, with 38 participants assigned to each group. Treatment allocation will be managed by an unblinded study team member. Outcome assessors will remain blinded to group assignment.
Participants in the intervention arm will receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months. Participants in the control arm will receive standard supportive care.
Eligible participants must have confirmed HPV positivity with low-grade cervical abnormalities, including ASC-US, LSIL, or CIN 1, and must not require an invasive cervical procedure such as biopsy, colposcopy-directed treatment, or LEEP during the 3-month study period.
The primary endpoint is HPV clearance at the end of 3 months, confirmed by repeat HPV testing and cervical cytology. Participants will be monitored monthly for treatment adherence and adverse events.
The planned sample size is 76 participants, with 38 participants per group, based on a two-sided alpha level of 0.05 and 80% statistical power.
The study was approved by the Kartal Dr. Lutfi Kirdar City Hospital Scientific Research Ethics Committee (Approval No. 2026/010.99/26/46).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either dual-modality immunotherapy or standard supportive care and followed in parallel for three months.
| Arm | Type | Receives |
|---|---|---|
| Dual-Modality Immunotherapy | Experimental | Drug: Oral Immunomodulator, Drug: Vaginal OvuleParticipants receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months. |
| Standard Supportive Care | Active comparator | Other: Standard Supportive CareParticipants receive standard supportive care for 3 months according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-65 years.
- Confirmed persistent high-risk human papillomavirus (HR-HPV) infection.
- Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL.
- Eligible for conservative follow-up without immediate excisional treatment.
- Ability to provide written informed consent and comply with study procedures.
Key exclusion criteria (7 listed)
- HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer.
- Pregnancy or breastfeeding.
- Immunodeficiency or current immunosuppressive therapy.
- Previous treatment for cervical dysplasia within the last 6 months.
- Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period.
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 |
|---|---|---|
| Oral ImmunomodulatorOral immunomodulator administered twice daily for 3 months. | Drug | Dual-Modality Immunotherapy |
| Vaginal OvuleVaginal ovule administered for 14 consecutive days each month for 3 months. | Drug | Dual-Modality Immunotherapy |
| Standard Supportive CareStandard supportive care according to routine clinical practice during the 3-month study period. | Other | Standard Supportive Care |
Primary outcome
HPV clearance rate
Time frame: 3 months
The proportion of participants with a negative high-risk HPV test at the end of the 3-month treatment period.
1 secondary outcome
Cytological regression
Time frame: 3 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 29 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not yet been determined. Data sharing may be considered after study completion upon reasonable request, subject to institutional policies, ethics committee approval, and applicable confidentiality requirements.
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A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
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Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
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PREVENT HPV -Related Cancers Trial
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Immunomodulator, Vaginal Ovule and Standard Supportive Care in people with Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia (CIN), run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV clearance rate (time frame: 3 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 29 Jul 2026.