Cervical DysplasiaPhase 3REVEAL 1NCT03185013
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
A Phase 3 study testing VGX-3100 and Electroporation (EP) in people with Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, run by Inovio Pharmaceuticals at 60 sites in 19 countries.
Trial summary
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
- What is being tested?
- VGX-3100 and Electroporation (EP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 60 sitesin 19 countries
- Study dates
- 28 Jun 2017to 6 Apr 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women aged 18 years and above
- Confirmed cervical infection with HPV types 16 and/or 18 at screening
- Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
- Confirmed histologic evidence of cervical HSIL at screening
- Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
- With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
- Normal screening electrocardiogram (ECG)
Who cannot join
- Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
- Cervical lesion(s) that cannot be fully visualized on colposcopy
- History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
- Treatment for cervical HSIL within 4 weeks prior to screening
- Pregnant, breastfeeding or considering becoming pregnant during the study
- History of previous therapeutic HPV vaccination
Show all 13Show fewer
- Immunosuppression as a result of underlying illness or treatment
- Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
- Receipt of any non-study, live vaccine within 4 weeks of Day 0
- Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
- Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
- Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
- Less than two acceptable sites available for IM injection
Trial locations and contacts
60 sites in 19 countries.
60 sites in 19 countries
United States22 sites
Augusta University
Augusta, Georgia, 30912
Chattanooga Medical Research Inc
Chattanooga, Tennessee, 37404
Women's Medical Research Group
Clearwater, Florida, 33759
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, 29615
UAG Innovation Women Research, LLC
Houston, Texas, 77074
Altus Research
Lake Worth, Florida, 33461
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
Women's Physician Group
Memphis, Tennessee, 38104
Mesa Obstetricians and Gynecologist
Mesa, Arizona, 85209
Salom and Tangir LLC
Miramar, Florida, 33461
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina, 29572
Columbia University Medical Center
New York, New York, 10032
New Jersey Medical School
Newark, New Jersey, 07103
Meridian Clinical Research Norfolk
Norfolk, Nebraska, 68701
Group For Women
Norfolk, Virginia, 23502
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Suffolk Obstetrics and Gynecology
Port Jefferson, New York, 11777
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604
Women's Health Research
Scottsdale, Arizona, 85251
Visions Clinical Research-Tucson
Tucson, Arizona, 85712
Comprehensive Clinical Trials LLC
West Palm Beach, Florida, 33409
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Argentina3 sites
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
DIM Clínica Privada
Ramos Mejía, B1704ETD
Instituto de Ginecología
Rosario, Santa Fe Province, S2000PBB
Estonia3 sites
Pärnu Hospital
Pärnu, Pärnumaa, EE-80010
East Tallinn Central Hospital Womens Clinic
Tallinn, 10119
Tartu University Hospital
Tartu, 51014
Italy3 sites
Istituto Europeo Di Oncologia
Milan, 20141
Istituto Nazionale Dei Tumori
Milan, 20133
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168
Poland3 sites
Centrum Medyczne Angelius Provita
Katowice, 40-611
Niepubliczny Zakład Opieki Zdrowotnej Profimed
Lublin, Lublin Voivodeship, 20-880
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lublin Voivodeship, 20-880
Spain3 sites
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Centre Hospitalier Universitaire Ambroise Paré
Mons, Hainaut, 7000
Finland2 sites
Kätilöopiston sairaala
Helsinki, 290
Lääkäriasema Cantti Oy
Kuopio, FI-70110
Germany2 sites
Elisabeth Krankenhaus Essen GmbH
Essen, 45138
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
Lithuania2 sites
Vilnius University Hospital Santaros Klinikos
Vilnius, LT- 08661
Vilnius District Central Outpatient Clinic
Vilnius, LT-01117
Peru2 sites
Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
Lima, 15083
Liga Peruana De Lucha Contra El Cancer
Lima, 15084
Portugal2 sites
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, 3000-075
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Slovakia2 sites
MCM GYNPED, s.r.o.
Dubnica nad Váhom, 018 41
Univerzitna nemocnica Martin
Martin, 036 59
South Africa2 sites
University of Cape Town
Cape Town, 7925
Lynette Reynders Private Practice
Centurion, Gauteng, 157
Thailand2 sites
Chulalongkorn University
Bangkok, 10700
Siriraj Hospital Mahidol University
Bangkok, 10700
United Kingdom2 sites
Aberdeen Royal Infirmary - PPDS
Aberdeen, AB25 7ZD
St Marys Hospital
London, W2 1NY
Mexico1 site
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340
Puerto Rico1 site
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras, 00935
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.
- Being tested
- VGX-3100, Placebo, Electroporation (EP)
- Keywords
- Cervical intraepithelial neoplasia (CIN), Human papillomavirus (HPV), High grade squamous intraepithelial lesion (HSIL), CIN 2, CIN 3, papillomavirus
- Medical subject headings
- Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGX-3100Biological
1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
PlaceboBiological
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Electroporation (EP)Device
Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
| Study group | Role | What they receive |
|---|---|---|
| VGX-3100 + EP | Experimental | Participants received three IM injections of 6 milligram (mg) (in 1 milliliter [mL]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. Receives: Biological: VGX-3100; Device: Electroporation (EP) |
| Placebo + EP | Placebo comparator | Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. Receives: Biological: Placebo; Device: Electroporation (EP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
Measured: Week 36
Secondary outcomes (10)
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Measured: From baseline up to Week 88
Percentage of Participants With No Evidence of Cervical HSIL on Histology
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL.
Measured: Week 36
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing
Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
Measured: Week 36
Percentage of Participants With No Evidence of LSIL or HSIL on Histology
Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.
Measured: Week 36
Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18
Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.
Measured: Week 36
Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma
Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.
Measured: Week 36
Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations
Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.
Measured: Week 36
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
Measured: Week 15 and Week 36
Change From Baseline in Interferon-Gamma Response Magnitude
Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.
Measured: Baseline; Week 15 and Week 36
Change From Baseline in Flow Cytometry Response Magnitude
Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start28 Jun 2017
- Primary completion8 Jul 2020
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Skolnik, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185013
- Sponsor's protocol ID
- HPV-301
- Other IDs
- 2016-002761-63, 2016
- Acronym
- REVEAL 1
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2017
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
- ClinicalTrials.gov ID
- NCT03185013
- Acronym / sponsor ID
- REVEAL 1 / HPV-301
- Keywords
- Cervical intraepithelial neoplasia (CIN), Human papillomavirus (HPV), High grade squamous intraepithelial lesion (HSIL), CIN 2, CIN 3, papillomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VGX-3100 + EP | Experimental | Biological: VGX-3100, Device: Electroporation (EP)Participants received three IM injections of 6 milligram (mg) (in 1 milliliter [mL]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Placebo + EP | Placebo comparator | Biological: Placebo, Device: Electroporation (EP)Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged 18 years and above
- Confirmed cervical infection with HPV types 16 and/or 18 at screening
- Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
- Confirmed histologic evidence of cervical HSIL at screening
- Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
Key exclusion criteria (13 listed)
- Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
- Cervical lesion(s) that cannot be fully visualized on colposcopy
- History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
- Treatment for cervical HSIL within 4 weeks prior to screening
- Pregnant, breastfeeding or considering becoming pregnant during the study
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 |
|---|---|---|
| VGX-31001 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. | Biological | VGX-3100 + EP |
| Placebo1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. | Biological | Placebo + EP |
| Electroporation (EP)Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device. | Device | Placebo + EP, VGX-3100 + EP |
Primary outcome
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples
Time frame: Week 36
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
10 secondary outcomes
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study
Time frame: From baseline up to Week 88
Percentage of Participants With No Evidence of Cervical HSIL on Histology
Time frame: Week 36
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing
Time frame: Week 36
Percentage of Participants With No Evidence of LSIL or HSIL on Histology
Time frame: Week 36
Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18
Time frame: Week 36
Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma
Time frame: Week 36
Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations
Time frame: Week 36
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Time frame: Week 15 and Week 36
Change From Baseline in Interferon-Gamma Response Magnitude
Time frame: Baseline; Week 15 and Week 36
Change From Baseline in Flow Cytometry Response Magnitude
Time frame: Baseline, Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Skolnik, MD study director
Inovio Pharmaceuticals
60 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VGX-3100 and Electroporation (EP) in people with Cervical Dysplasia and Cervical High Grade Squamous Intraepithelial Lesion, run by Inovio Pharmaceuticals at 60 sites in 19 countries.
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 13 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Argentina, Estonia, Italy, Poland and 14 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples (time frame: Week 36). 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 27 Jul 2023.