Trial · NCT07572396
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
NCT07572396, Phase 2, Recruiting, Amplexd Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities. Trials, record NCT07572396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07572396
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
- NCT number
- NCT07572396
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 45 participants, estimated
- Lead sponsor
- Amplexd Therapeutics, Inc.
- Conditions
- High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US, HPV Infection, Cervical Abnormalities, Uterine Cervical Dysplasia
- Interventions
- EGCG and Quinine Sulfate Vaginal Suppository, Placebo
- First posted
- 2026-05-07
- Last updated
- 2026-05-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine and evaluate the safety and tolerability of Dysplasix™ intravaginal suppository therapy in females with hr-HPV and positive cytology for either ASCUS or LSIL. | From enrollment until post-end of treatment follow up (Day 50 visit) | Number of participants with serious adverse events (SAEs) or dose-limiting toxicities (DLTs) related to the study intervention assessed using relevant Common Terminology Criteria for Adverse Events (CTCAE). |
| Primary | Regression of cervical cytology present at study entry | From enrollment to post-end of treatment follow-up (Day 50 visit) | Participants whose baseline Atypical Cells of Undetermined Significance (ASCUS) or Low-Grade Squamous Intraepithelial Lesions (LSIL) regress to Normal for Intraepithelial Lesions or Malignancies (NILM), 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by cytology |
| Primary | Clearance of hr-HPV genotype present at study entry | From enrollment to post-end of treatment follow-up (Day 50 visit) | Participants whose high-risk human papillomavirus (HPV) genotypes present at study entry become undetectable 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by HPV testing |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07572396
GET https://conductscience.org/api/trials/v1/NCT07572396/registered