Clinical trial · Interventional
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
NCT04098744CI-TRIAL-00096127ART-CIN_IIBrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
| HPV Infection | — | UNRESOLVED | — |
| HPV Related Disease | — | UNRESOLVED | — |
| Pre-Cancerous Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate vaginal insert | Drug | — | UNRESOLVED |
| Placebo vaginal insert | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Artesunate vaginal insert
- description
- Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
- interventionNames
- Drug: Artesunate vaginal insert
- type
- PLACEBO_COMPARATOR
- label
- Placebo vaginal inserts
- description
- Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
- interventionNames
- Drug: Placebo vaginal insert
Primary outcomes (1)
- measure
- Proportion of participants with histologic regression by week 17
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adult females age ≥ 25 years * Capable of informed consent * Any HPV genotype detectable by DNA test/HPV genotyping * Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3) * Women of childbearing potential agree to use birth control through week17 of the study. * Weight ≥ 50kg Exclusion Criteria: * Pregnant and nursing women * Active autoimmune disease * Taking immunosuppressive medication * HIV seropositivity * Immunocompromised subjects * Evidence of concurrent cervical adenocarcinoma in situ * Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
References
Publications (0)
Data not yet available
No reference posted for this study.