Cervix DysplasiaHPV-VG1NCT05509413
DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections
A study testing DEFLAGYN vaginal gel in people with Cervix Dysplasia and HPV Infection, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Dysplasia, HPV Infection
- What is being tested?
- DEFLAGYN vaginal gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2022to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent
- Unclear cervical smear (ASC-US, ASC-H, LSIL, HSIL or PAP II-p, PAP III-p, PAP IIID1, PAP IIID2 (Munich III) or PAP III, PAP IIID, PAP I + HPV high-risk infection)
Who cannot join
- Pregnancy
- Known hypersensitivity to any of the ingredients of the vaginal gel
- Insufficient knowledge of the German language
- Pre-existing oncological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Precancerous lesions (dysplasias) or the presence of a high-risk HPV subtype are detected by a screening smear test performed by a gynecologist. If precancerous lesions are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. However, if the degree of dysplasia is correspondingly low or the smear is unclear, then the guideline-compliant non-surgical treatment provides for a wait-and-see approach with PAP and HPV smear control after 6-8 months.
This "wait-and-see" approach can be complemented by local therapy with an immunostimulant. For this purpose, DEFLAGYN® (a vaginal gel containing silica and citric acid) and Aldara® (imiquimod, a Toll-Like Re-ceptor 7 antagonist) are available. However, while the latter is not approved for the treatment of cervical dysplasia or HPV infection, DEFLAGYN® has CE marking and approval as a medical device for treatment in a number of indications, such as unclear cervical smears, HPV-induced cervical lesions, p16/Ki-67-positive cervical lesions or cervical erosions.
Read more
However, available studies on the efficacy of DEFLAGYN are limited. For example, there is only one prospective randomized trial (Major et al, 2021, Arch. Gynecol. Obstet. 303:501-511), which included 216 women with histologically confirmed CIN 1/2. A 3-month intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). Side effects of therapy with DEFLAGYN® were not observed in this study.
Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of treating this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® should be performed.
Read the detailed description
- HPV and dysplasia of the cervix uteri Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in both male and female populations is high. Epidemiological estimates suggest that 85-91% of sexually active adults acquire at least one genital HPV infection by age 50, with approximately 95% of HPV infections being spontaneously eliminated within 2 years in terms of HPV immunologic clearance. HPV preferentially infects the epithelial cells of the anogenital area and, through incorporation of HPV DNA into the host genome of the basal cells of the squamous epithelium of the cervix and subsequent expression of viral components, causes dysplastic changes in the cervical epithelium that, if left untreated, can develop into invasive carcinoma of the cervix (cervical carcinoma). Cervical carcinoma is the fourth most common cancer as well as the fourth leading cause of cancer-related death in women worldwide, responsible for 6.6% (570,000) of all new cancer cases and 7.5% (311,000) of cancer-related deaths in women in 2018. The precursor of squamous cell carcinoma of the uterine cervix (approximately 80% of all cervical cancers) is cervical intraepithelial neoplasia (CIN), which has three grades of expression (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the incidence and prevalence of precancerous lesions of the cervix uteri are much higher. It is estimated that approximately 100,00 w0omen in Germany develop high-grade dysplasia (CIN2/CIN3) each year.
- Therapy Dysplasia of the cervix typically becomes conspicuous during gynecological screening examinations. Here, smears are taken from the ectocervix and endocervix and assessed cytologically for dysplastic cells and the quality of the smear after Papanicolaou staining. HPV infection diagnostics are also performed as part of the statutory cervical carcinoma screening (annually or every 3 years) in order to detect the presence of HPV high risk infections. In case of abnormalities in the cervical smear and/or HPV high risk infection with suspicion of cervical dysplasia, presentation to a specialized dysplasia consultation is recommended for further clarification of dysplastic changes. During the subsequent colposcopic examination, a histological tissue sample ('cervical biopsy') of conspicuous areas is taken. The histopathological processing of the tissue samples and the colposcopic image of the spread of the changes in the cervix then allow individualized therapy planning.
- Conization as the standard of surgical treatment If precancerous lesions with the potential to develop into an invasive cervical tumor are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. The worldwide standard surgical procedure for conization is LLETZ conization (="Large Loop Excision of the Transformation Zone"). In addition to the risk of local persistence of precancerous lesions if cervical dysplasia is incompletely removed, LLETZ also increases the risk of preterm delivery in subsequent pregnancy. This risk increases with increasing volume of removed tissue. To reduce or avoid the aforementioned complications, conization should be performed under colposcopic vision and as little healthy cervical tissue as possible should be removed.
- Non-surgical treatment options Non-surgical methods for the treatment of CIN and/or HPV high risk infections are limited. According to the current S3 guideline, in case of CIN 1 and/or HPV high risk infection, a wait-and-see approach with PAP and HPV smear control in 6-8 months is possible. Alternatively, local therapy with an immunostimulant may be used. DEFLAGYN® and Aldara® are available for this purpose. Aldara® is imiquimod, a Toll-Like Receptor 7 (TLR 7) antagonist, which leads to a local immune response. However, Aldara® is not approved for the treatment of CIN or HPV infections. DEFLAGYN®, on the other hand, has a CE mark and medical device approval for the treatment of unclear cervical smears (ASC-US, ASC-H, LSIL, HSIL or PAP II-p, PAP III-p, PAP IIID1, PAP IIID2 or PAP III, PAP IIID) or HPV-induced cervical lesions or p16/Ki-67-positive cervical lesions or cervical erosions.
- DEFLAGYN® - Mode of action and approval status DEFLAGYN® is a vaginal gel containing silica and citric acid, which binds pathogens, inhibits their spread and exerts an antioxidant effect. It is applied intravaginally and used for 3 months. In a prospective randomized study of 216 women with histologically confirmed CIN 1/2, 3 months of intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). The rate of HPV high risk infections decreased from 87% to 44% in the intervention arm. No other intervention studies on the efficacy of DEFLAGYN® can be found in the literature (PubMed search on 08/14/2022; search terms: dysplasia, deflagyn, HPV, silicon dioxide gel, randomized). Side effects of therapy with DEFLAGYN® were not observed in the study. Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® are useful.
- Conditions
- Cervix Dysplasia, HPV Infection
- Being tested
- DEFLAGYN vaginal gel
- Keywords
- cervical dysplasia, unclear cytology, HPV infection
- Medical subject headings
- Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEFLAGYN vaginal gelDevice
DEFLAGYN is a vaginal gel, classified as a medical device, containing silica and citric acid, which binds pathogens, inhibits their spread and exerts an antioxidant effect. It is applied intravaginally (through an applicator) and used for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Wait-and-see approach. |
| DEFLAGYN Arm | Experimental | Application of DEFLAGYN vaginal gel for 3x 28days (as per instructions provided by the manufacturer) Receives: Device: DEFLAGYN vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hr-HPV-positive cervical smears
The rate of hr-HPV-positive findings after 3 months.
Measured: 3 months after initial examination/study inclusion
Secondary outcomes (4)
Rate of hr-HPV-positive cervical smears
The rate of hr-HPV-positive findings after 6 months.
Measured: 6 months after initial examination/study inclusion
Rate of progression
The rate of progression (in case of mild dysplasia at start)
Measured: 3 and 6 months after initial examination/study inclusion
Rate of newly diagnosed dysplasia
The rates of newly diagnosed (i.e. not present during initial examination at study start) dysplasia or malignancies
Measured: 3 and 6 months after initial examination/study inclusion
Complications
The number and kind of complications during the first 3 months
Measured: From study inclusion/treatment start until the 3-month-follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start8 Nov 2022
- Primary completion23 May 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cervix DysplasiaStudies 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
- 1:1 randomization into a control arm (wait-and-see) and a treatment arm (vaginal gel)
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Tempfer, Ruhr University of Bochum
- Investigators
- Clemens B Tempfer, MD, MBA, Principal investigator, Ruhr-Universität Bochum, Marien Hospital Herne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509413
- Sponsor's protocol ID
- HPV-VG1
- Acronym
- HPV-VG1
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request made to the corresponding author. This includes individual participant data underlying the results presented here, after deidentification, as well as data dictionaries and the the study protocol. Data is available after publication, without a specific end date. Requesting investigators must show that their proposed use of the data has been approved by an independent review committee identified for this purpose.
Publications
Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
PubMed 34292926Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014 Nov;41(11):660-4. doi: 10.1097/OLQ.0000000000000193.
PubMed 25299412Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Mathevet P, Chemali E, Roy M, Dargent D. Long-term outcome of a randomized study comparing three techniques of conization: cold knife, laser, and LEEP. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):214-8. doi: 10.1016/s0301-2115(02)00245-2.
PubMed 12551795Bevis KS, Biggio JR. Cervical conization and the risk of preterm delivery. Am J Obstet Gynecol. 2011 Jul;205(1):19-27. doi: 10.1016/j.ajog.2011.01.003. Epub 2011 Feb 23.
PubMed 21345402Jin G, LanLan Z, Li C, Dan Z. Pregnancy outcome following loop electrosurgical excision procedure (LEEP) a systematic review and meta-analysis. Arch Gynecol Obstet. 2014 Jan;289(1):85-99. doi: 10.1007/s00404-013-2955-0. Epub 2013 Jul 11.
PubMed 23843155Khalid S, Dimitriou E, Conroy R, Paraskevaidis E, Kyrgiou M, Harrity C, Arbyn M, Prendiville W. The thickness and volume of LLETZ specimens can predict the relative risk of pregnancy-related morbidity. BJOG. 2012 May;119(6):685-91. doi: 10.1111/j.1471-0528.2011.03252.x. Epub 2012 Feb 14.
PubMed 22329499Shaco-Levy R, Eger G, Dreiher J, Benharroch D, Meirovitz M. Positive margin status in uterine cervix cone specimens is associated with persistent/recurrent high-grade dysplasia. Int J Gynecol Pathol. 2014 Jan;33(1):83-8. doi: 10.1097/PGP.0b013e3182763158.
PubMed 24300540Preaubert L, Gondry J, Mancini J, Chevreau J, Lamblin G, Atallah A, Lavoue V, Caradec C, Baldauf JJ, Bryand A, Henno S, Villeret J, Agostini A, Douvier S, Jarniat A, Riethmuller D, Mendel A, Brun JL, Rakotomahenina H, Carcopino X. Benefits of Direct Colposcopic Vision for Optimal LLETZ Procedure: A Prospective Multicenter Study. J Low Genit Tract Dis. 2016 Jan;20(1):15-21. doi: 10.1097/LGT.0000000000000156.
PubMed 26704328Kuhn W. [Colposcopy in the diagnosis of early cervical cancer]. Pathologe. 2011 Nov;32(6):497-504. doi: 10.1007/s00292-011-1480-9. German.
PubMed 21984389Major AL, Dvorak V, Schwarzova J, Skrivanek A, Malik T, Pluta M, Mayboroda I, Grandjean EM. Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial. Arch Gynecol Obstet. 2021 Feb;303(2):501-511. doi: 10.1007/s00404-020-05816-8. Epub 2020 Nov 20.
PubMed 33219482Major AL, Skrivanek A, Grandjean EM, Dvorak V, Malik T, Pluta M, Mayboroda I. An Adsorptive and Antioxidant Vaginal Gel Clears High-Risk HPV- and p16/Ki-67-Associated Abnormal Cytological Cervical Findings: A post-hoc Subgroup Analysis of a Prospective Randomized Controlled Trial on CIN2 and p16 Positive CIN1. Front Med (Lausanne). 2021 May 25;8:645559. doi: 10.3389/fmed.2021.645559. eCollection 2021.
PubMed 34113633Hecken JM, Tempfer CB, Klaus K, Scheich J, Rezniczek GA. Silicon dioxide vaginal gel and short-term high-risk human papillomavirus DNA detectability: A randomized controlled trial. Acta Obstet Gynecol Scand. 2026 Aug 5. doi: 10.1111/aogs.70332. Online ahead of print.
PubMed 42557865
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections
- ClinicalTrials.gov ID
- NCT05509413
- Acronym / sponsor ID
- HPV-VG1 / HPV-VG1
- Conditions
- Cervix Dysplasia, HPV Infection
- Keywords
- cervical dysplasia, unclear cytology, HPV infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 22 Aug 2022 (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.
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Precancerous lesions (dysplasias) or the presence of a high-risk HPV subtype are detected by a screening smear test performed by a gynecologist. If precancerous lesions are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. However, if the degree of dysplasia is correspondingly low or the smear is unclear, then the guideline-compliant non-surgical treatment provides for a wait-and-see approach with PAP and HPV smear control after 6-8 months.
This "wait-and-see" approach can be complemented by local therapy with an immunostimulant. For this purpose, DEFLAGYN® (a vaginal gel containing silica and citric acid) and Aldara® (imiquimod, a Toll-Like Re-ceptor 7 antagonist) are available. However, while the latter is not approved for the treatment of cervical dysplasia or HPV infection, DEFLAGYN® has CE marking and approval as a medical device for treatment in a number of indications, such as unclear cervical smears, HPV-induced cervical lesions, p16/Ki-67-positive cervical lesions or cervical erosions.
However, available studies on the efficacy of DEFLAGYN are limited. For example, there is only one prospective randomized trial (Major et al, 2021, Arch. Gynecol. Obstet. 303:501-511), which included 216 women with histologically confirmed CIN 1/2. A 3-month intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). Side effects of therapy with DEFLAGYN® were not observed in this study.
Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of treating this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® should be performed.
Detailed description
- HPV and dysplasia of the cervix uteri Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in both male and female populations is high. Epidemiological estimates suggest that 85-91% of sexually active adults acquire at least one genital HPV infection by age 50, with approximately 95% of HPV infections being spontaneously eliminated within 2 years in terms of HPV immunologic clearance. HPV preferentially infects the epithelial cells of the anogenital area and, through incorporation of HPV DNA into the host genome of the basal cells of the squamous epithelium of the cervix and subsequent expression of viral components, causes dysplastic changes in the cervical epithelium that, if left untreated, can develop into invasive carcinoma of the cervix (cervical carcinoma). Cervical carcinoma is the fourth most common cancer as well as the fourth leading cause of cancer-related death in women worldwide, responsible for 6.6% (570,000) of all new cancer cases and 7.5% (311,000) of cancer-related deaths in women in 2018. The precursor of squamous cell carcinoma of the uterine cervix (approximately 80% of all cervical cancers) is cervical intraepithelial neoplasia (CIN), which has three grades of expression (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the incidence and prevalence of precancerous lesions of the cervix uteri are much higher. It is estimated that approximately 100,00 w0omen in Germany develop high-grade dysplasia (CIN2/CIN3) each year.
- Therapy Dysplasia of the cervix typically becomes conspicuous during gynecological screening examinations. Here, smears are taken from the ectocervix and endocervix and assessed cytologically for dysplastic cells and the quality of the smear after Papanicolaou staining. HPV infection diagnostics are also performed as part of the statutory cervical carcinoma screening (annually or every 3 years) in order to detect the presence of HPV high risk infections. In case of abnormalities in the cervical smear and/or HPV high risk infection with suspicion of cervical dysplasia, presentation to a specialized dysplasia consultation is recommended for further clarification of dysplastic changes. During the subsequent colposcopic examination, a histological tissue sample ('cervical biopsy') of conspicuous areas is taken. The histopathological processing of the tissue samples and the colposcopic image of the spread of the changes in the cervix then allow individualized therapy planning.
- Conization as the standard of surgical treatment If precancerous lesions with the potential to develop into an invasive cervical tumor are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. The worldwide standard surgical procedure for conization is LLETZ conization (="Large Loop Excision of the Transformation Zone"). In addition to the risk of local persistence of precancerous lesions if cervical dysplasia is incompletely removed, LLETZ also increases the risk of preterm delivery in subsequent pregnancy. This risk increases with increasing volume of removed tissue. To reduce or avoid the aforementioned complications, conization should be performed under colposcopic vision and as little healthy cervical tissue as possible should be removed.
- Non-surgical treatment options Non-surgical methods for the treatment of CIN and/or HPV high risk infections are limited. According to the current S3 guideline, in case of CIN 1 and/or HPV high risk infection, a wait-and-see approach with PAP and HPV smear control in 6-8 months is possible. Alternatively, local therapy with an immunostimulant may be used. DEFLAGYN® and Aldara® are available for this purpose. Aldara® is imiquimod, a Toll-Like Receptor 7 (TLR 7) antagonist, which leads to a local immune response. However, Aldara® is not approved for the treatment of CIN or HPV infections. DEFLAGYN®, on the other hand, has a CE mark and medical device approval for the treatment of unclear cervical smears (ASC-US, ASC-H, LSIL, HSIL or PAP II-p, PAP III-p, PAP IIID1, PAP IIID2 or PAP III, PAP IIID) or HPV-induced cervical lesions or p16/Ki-67-positive cervical lesions or cervical erosions.
- DEFLAGYN® - Mode of action and approval status DEFLAGYN® is a vaginal gel containing silica and citric acid, which binds pathogens, inhibits their spread and exerts an antioxidant effect. It is applied intravaginally and used for 3 months. In a prospective randomized study of 216 women with histologically confirmed CIN 1/2, 3 months of intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). The rate of HPV high risk infections decreased from 87% to 44% in the intervention arm. No other intervention studies on the efficacy of DEFLAGYN® can be found in the literature (PubMed search on 08/14/2022; search terms: dysplasia, deflagyn, HPV, silicon dioxide gel, randomized). Side effects of therapy with DEFLAGYN® were not observed in the study. Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® are useful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization into a control arm (wait-and-see) and a treatment arm (vaginal gel)
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Wait-and-see approach. |
| DEFLAGYN Arm | Experimental | Device: DEFLAGYN vaginal gelApplication of DEFLAGYN vaginal gel for 3x 28days (as per instructions provided by the manufacturer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written consent
- Unclear cervical smear (ASC-US, ASC-H, LSIL, HSIL or PAP II-p, PAP III-p, PAP IIID1, PAP IIID2 (Munich III) or PAP III, PAP IIID, PAP I + HPV high-risk infection)
Key exclusion criteria (4 listed)
- Pregnancy
- Known hypersensitivity to any of the ingredients of the vaginal gel
- Insufficient knowledge of the German language
- Pre-existing oncological diseases
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 |
|---|---|---|
| DEFLAGYN vaginal gelDEFLAGYN is a vaginal gel, classified as a medical device, containing silica and citric acid, which binds pathogens, inhibits their spread and exerts an antioxidant effect. It is applied intravaginally (through an applicator) and used for 3 months. | Device | DEFLAGYN Arm |
Primary outcome
Rate of hr-HPV-positive cervical smears
Time frame: 3 months after initial examination/study inclusion
The rate of hr-HPV-positive findings after 3 months.
4 secondary outcomes
Rate of hr-HPV-positive cervical smears
Time frame: 6 months after initial examination/study inclusion
Rate of progression
Time frame: 3 and 6 months after initial examination/study inclusion
Rate of newly diagnosed dysplasia
Time frame: 3 and 6 months after initial examination/study inclusion
Complications
Time frame: From study inclusion/treatment start until the 3-month-follow up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 34292926Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
- Background: PubMed 25299412Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014 Nov;41(11):660-4. doi: 10.1097/OLQ.0000000000000193.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 12551795Mathevet P, Chemali E, Roy M, Dargent D. Long-term outcome of a randomized study comparing three techniques of conization: cold knife, laser, and LEEP. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):214-8. doi: 10.1016/s0301-2115(02)00245-2.
- Background: PubMed 21345402Bevis KS, Biggio JR. Cervical conization and the risk of preterm delivery. Am J Obstet Gynecol. 2011 Jul;205(1):19-27. doi: 10.1016/j.ajog.2011.01.003. Epub 2011 Feb 23.
- Background: PubMed 23843155Jin G, LanLan Z, Li C, Dan Z. Pregnancy outcome following loop electrosurgical excision procedure (LEEP) a systematic review and meta-analysis. Arch Gynecol Obstet. 2014 Jan;289(1):85-99. doi: 10.1007/s00404-013-2955-0. Epub 2013 Jul 11.
- Background: PubMed 22329499Khalid S, Dimitriou E, Conroy R, Paraskevaidis E, Kyrgiou M, Harrity C, Arbyn M, Prendiville W. The thickness and volume of LLETZ specimens can predict the relative risk of pregnancy-related morbidity. BJOG. 2012 May;119(6):685-91. doi: 10.1111/j.1471-0528.2011.03252.x. Epub 2012 Feb 14.
- Background: PubMed 24300540Shaco-Levy R, Eger G, Dreiher J, Benharroch D, Meirovitz M. Positive margin status in uterine cervix cone specimens is associated with persistent/recurrent high-grade dysplasia. Int J Gynecol Pathol. 2014 Jan;33(1):83-8. doi: 10.1097/PGP.0b013e3182763158.
- Background: PubMed 26704328Preaubert L, Gondry J, Mancini J, Chevreau J, Lamblin G, Atallah A, Lavoue V, Caradec C, Baldauf JJ, Bryand A, Henno S, Villeret J, Agostini A, Douvier S, Jarniat A, Riethmuller D, Mendel A, Brun JL, Rakotomahenina H, Carcopino X. Benefits of Direct Colposcopic Vision for Optimal LLETZ Procedure: A Prospective Multicenter Study. J Low Genit Tract Dis. 2016 Jan;20(1):15-21. doi: 10.1097/LGT.0000000000000156.
- Background: PubMed 21984389Kuhn W. [Colposcopy in the diagnosis of early cervical cancer]. Pathologe. 2011 Nov;32(6):497-504. doi: 10.1007/s00292-011-1480-9. German.
- Background: PubMed 33219482Major AL, Dvorak V, Schwarzova J, Skrivanek A, Malik T, Pluta M, Mayboroda I, Grandjean EM. Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial. Arch Gynecol Obstet. 2021 Feb;303(2):501-511. doi: 10.1007/s00404-020-05816-8. Epub 2020 Nov 20.
- Background: PubMed 34113633Major AL, Skrivanek A, Grandjean EM, Dvorak V, Malik T, Pluta M, Mayboroda I. An Adsorptive and Antioxidant Vaginal Gel Clears High-Risk HPV- and p16/Ki-67-Associated Abnormal Cytological Cervical Findings: A post-hoc Subgroup Analysis of a Prospective Randomized Controlled Trial on CIN2 and p16 Positive CIN1. Front Med (Lausanne). 2021 May 25;8:645559. doi: 10.3389/fmed.2021.645559. eCollection 2021.
- German S3 GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request made to the corresponding author. This includes individual participant data underlying the results presented here, after deidentification, as well as data dictionaries and the the study protocol. Data is available after publication, without a specific end date. Requesting investigators must show that their proposed use of the data has been approved by an independent review committee identified for this purpose.
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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.
Clemens B Tempfer, MD, MBA principal investigator
Ruhr-Universität Bochum, Marien Hospital Herne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEFLAGYN vaginal gel in people with Cervix Dysplasia and HPV Infection, run by Ruhr University of Bochum at 1 site in Germany.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of hr-HPV-positive cervical smears (time frame: 3 months after initial examination/study inclusion). 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 NCT05509413, which also lists 13 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 18 Nov 2025.