Artesunate Vaginal Inserts for the Treatment of CIN2/3 (ART_CIN_II)
|ClinicalTrials.gov Identifier: NCT04098744|
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : April 8, 2020
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).
Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.
|Condition or disease||Intervention/treatment||Phase|
|CIN 2/3 HPV Infection Pre-Cancerous Dysplasia Cervical Dysplasia||Drug: Artesunate vaginal insert Drug: Placebo vaginal insert||Phase 2|
Eligible participants in this study are randomized 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. Participants are followed closely with colposcopies at weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is unblinded. Participants in the placebo group who still have CIN2/3 have the option to start treatment with artesunate within 4 weeks. Participants in the artesunate treatment who still have CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or cold knife conization) within 6 weeks.
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.
- 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 histopathologic regression after the week 15 time point
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)|
|Estimated Study Start Date :||May 15, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Drug: Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Placebo Comparator: Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit.
Drug: Placebo vaginal insert
Placebo for artesunate vaginal inserts
- Proportion of subjects with histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15 [ Time Frame: 15 weeks ]Number of participants who have histologic regression of CIN2/3 to CIN1 within the study window (15 weeks)
- Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15 [ Time Frame: 15 weeks ]Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks)
- Number of participants with Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 28 weeks ]Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention
- Number of participants who withdrew from the study due to TEAEs [ Time Frame: 28 weeks ]Number of participants who were withdrawn from the study due to adverse events related to the study drug
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098744
|Contact: Mihaela Plesa, BAemail@example.com|
|Contact: Ahmad Bayat, MD||(301) firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Outpatient Center|
|Baltimore, Maryland, United States, 21205|
|Contact: Cornelia Trimble, MD 410-502-0512 email@example.com|
|Contact: Maria Hom 410-502-0512 firstname.lastname@example.org|
|Principal Investigator: Cornelia L Trimble, MD|
|United States, Texas|
|The Harris Health System|
|Houston, Texas, United States, 77026|
|Contact: Jessica Gallegos 713-563-4580 email@example.com|
|Contact: Cindy Melendez 713-563-4582 firstname.lastname@example.org|
|Principal Investigator:||Cornelia L Trimble, MD||Johns Hopkins University|