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New treatment option for High-risk HPV (Any Strain)
Official title Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
ClinicalTrials.gov ID: NCT07572396
What this study is testing
What is EGCG and Quinine Sulfate Vaginal Suppository?
EGCG and Quinine Sulfate Vaginal Suppository is an investigational medicine, given as an once-daily, being studied as a potential treatment for high-risk hpv (any strain).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Participants must meet all the following criteria to be eligible to enroll in the study:
- Participants capable of giving informed consent
- Females, ages 18 to 65 years old at the time of signature of the informed consent form.
- Participants who are able to correctly self-administer the intravaginal suppositories
- One or more hr-HPV oncotypes as confirmed by HPV test
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study:
- Presence of HSIL at screening cytology
- Evidence of glandular abnormalities (AGC/AIS) at screening cytology
- BMI below 16
- Pregnant or nursing females
- Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
See the full eligibility criteria
- Participants must meet all the following criteria to be eligible to enroll in the study:
- Participants capable of giving informed consent
- Females, ages 18 to 65 years old at the time of signature of the informed consent form.
- Participants who are able to correctly self-administer the intravaginal suppositories
- One or more hr-HPV oncotypes as confirmed by HPV test
- Participants with ASCUS or LSIL abnormalities as confirmed by cytology
- Immune competent
- Participants of childbearing potential must have a negative pregnancy test at screening.
- Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
- Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study
- Participants meeting any of the following criteria will be excluded from the study:
- Presence of HSIL at screening cytology
- Evidence of glandular abnormalities (AGC/AIS) at screening cytology
- BMI below 16
- Pregnant or nursing females
- Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
- Using a vaginal contraceptive ring
- History of irregular menstrual cycles or routine intermenstrual bleeding
- Active autoimmune disease
- Taking prohibited concomitant medications
- Concurrent malignancy except for non-melanoma skin lesions
- Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, New Territories, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, New Territories, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.