Clinical trial · Interventional
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The main questions it aims to answer are: * Does the investigational therapy lead to regression of cervical lesions? * Does the investigational therapy help clear hr-HPV infection? * Do any adverse effects occur from using this medical product? Researchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works. Participants will: * Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility * Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days * Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months * Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes * Keep a daily diary of investigational therapy use and associated information
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASC-US | — | UNRESOLVED | — |
| Cervical Abnormalities | — | UNRESOLVED | — |
| High-risk HPV (Any Strain) | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| LSIL, Low Grade Squamous Intraepithelial Lesion | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGCG and Quinine Sulfate Vaginal Suppository | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dysplasix™ Intravaginal Suppositories
- description
- Epigallocatechin gallate + Quinine Sulfate - Semisolid Intravaginal Suppository; 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.
- interventionNames
- Drug: EGCG and Quinine Sulfate Vaginal Suppository
- type
- PLACEBO_COMPARATOR
- label
- Placebo Intravaginal Suppositories
- description
- Semisolid Intravaginal Suppository - 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Participants must meet all the following criteria to be eligible to enroll in the study: 1. Participants capable of giving informed consent 2. Females, ages 18 to 65 years old at the time of signature of the informed consent form. 3. Participants who are able to correctly self-administer the intravaginal suppositories 4. One or more hr-HPV oncotypes as confirmed by HPV test 5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology 6. Immune competent 7. Participants of childbearing potential must have a negative pregnancy test at screening. 8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study 9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Presence of HSIL at screening cytology 2. Evidence of glandular abnormalities (AGC/AIS) at screening cytology 3. BMI below 16 4. Pregnant or nursing females 5. Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens 6. Using a vaginal contraceptive ring 7. History of irregular menstrual cycles or routine intermenstrual bleeding 8. Active autoimmune disease 9. Taking prohibited concomitant medications 10. Concurrent malignancy except for non-melanoma skin lesions 11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)
References
Publications (0)
Data not yet available