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Artesunate Vaginal Inserts for Cervical Dysplasia (ART-CIN_IIB Trial)
ART-CIN_IIB Trial Summary
This trial is testing a vaginal insert containing Artesunate for the treatment of CIN2/3 in women. The insert will be compared to a placebo insert to see if it is effective.
ART-CIN_IIB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:ART-CIN_IIB Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ART-CIN_IIB Trial Design
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Who is running the clinical trial?
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- I have a confirmed diagnosis of a high-grade cervical precancer.I weigh at least 110 pounds.I agree to use birth control until week 28 of the study.I have no other cancers except for non-dangerous skin lesions.I have a diagnosis of early-stage cervical cancer.I am a woman aged 25 or older.I understand the information given to me and can make decisions about my health care.I am a woman aged 25 or older.I have been diagnosed with high grade cervical lesions.My immune system is weakened.My test shows I have an HPV infection.I weigh at least 50kg.I am HIV positive.I have a non-invasive cervical cancer.I have an active autoimmune disease.
- Group 1: Placebo vaginal inserts
- Group 2: Artesunate vaginal insert
- Screening: It may take up to 6 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 5 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people still being accepted for this experiment?
"Yes. The clinical trial is recruiting for 78 patients across 8 locations, as indicated on the website clinicaltrials.gov. This information was last updated on 9/12/2022, and the trial was initially posted on 9/9/2020."
What is the clinical efficacy of Artesunate vaginal insert?
"Artesunate vaginal insert was first studied in the year 2017 at University Hospitals of Derby and Burton NHS Foundation Trust. Since then there have been 118 completed studies with 12 clinical trials currently recruiting patients. Many of these studies are being performed out of Ann Arbor, Michigan."
What are the goals that researchers hope to achieve with this clinical trial?
"The primary outcome of this trial, which will be measured over a 15 week time frame is the Proportion of participants with histologic regression by week 17. Secondary outcomes include: the Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17, defined as the Number of participants who had HPV strains detected at study entry which become undetectable by week 17; the Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure, defined as the Number of participants who had HPV"
How many people are currently a part of this research project?
"That is correct. Based on the information available from clinicaltrials.gov, this specific trial is searching for patients and was last updated September 12th, 2022. They are looking for 78 people total across 8 sites."
What is the FDA's stance on Artesunate vaginal insert?
"Although there is lack of data regarding Artesunate vaginal insert's efficacy, it has been determined to be safe in Phase 2 trials. Consequently, our team gives it a safety rating of 2."
Is this research project open to applicants who are still young?
"In order to participate in this clinical trial, applicants must be aged 25-100. There are a total of 34 studies for patients under 18 and 102 for those over 65 years old."
At how many hospitals or other medical facilities is this research being conducted?
"Patients can enroll at 8 different locations including Ann Arbor, Brightwaters and Mayfield Heights. The other enrolment centres are located near these cities. If you decide to participate in this trial, try to select the closest location to minimize travel time and expenses."
Might I be able to enroll in this particular clinical trial?
"This study is recruiting 78 people with immunoglobulin g4-related disease between the ages of 25 and 100. Most notable, patients must meet the following criteria: Adult females age ≥ 25 years, Capable of informed consent, 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 week 28 of the study., Weight ≥ 50kg, Any HPV genotype detectable by DNA test/HPV genotyping."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- Cleveland Clinic Fairview Hospital: < 48 hours
Typically responds via
Average response time
- < 2 Days
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