Trials / Recruiting
RecruitingNCT04098744
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- Frantz Viral Therapeutics, LLC · Industry
- Sex
- Female
- Age
- 25 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17. Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. Secondary Objectives: * To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3 * To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. * To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Artesunate vaginal insert | Artesunate formulated as vaginal inserts, 200mg |
| DRUG | Placebo vaginal insert | Placebo for artesunate vaginal inserts |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2026-07-31
- Completion
- 2026-12-31
- First posted
- 2019-09-23
- Last updated
- 2025-10-02
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04098744. Inclusion in this directory is not an endorsement.