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Could a malaria drug treat cervical Pre-Cancer?

NCT ID NCT04098744

Disease control Sponsor: Frantz Viral Therapeutics, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests whether artesunate, a drug originally used for malaria, can reverse cervical pre-cancer (CIN2/3) when given as a vaginal insert. About 78 women with high-grade cervical lesions will receive either artesunate or a placebo for three 5-day cycles. The main goal is to see if the lesions shrink or disappear by week 17, potentially offering a non-surgical treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artesunate vaginal insert
What this could lead to
If it works, this could provide a non-surgical treatment for cervical pre-cancer, potentially reducing the need for procedures like LEEP.
What could go wrong
This is a small, early-phase trial with only 78 participants. It may not show enough benefit over placebo, and the treatment is still experimental with unknown long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 dysplasia of cervix human papilloma virus infection precancerous condition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical dysplasia Cin 2/3 HPV infection HPV related disease Pre-cancerous dysplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cleveland Clinic Fairview Hospital

    RECRUITING

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Florida Gynecologic Oncology

    RECRUITING

    Fort Myers, Florida, 33905, United States

  • Hillcrest Hospital

    RECRUITING

    Mayfield Heights, Ohio, 44124, United States

  • The Harris Health System (L.B.J Hospital)

    RECRUITING

    Houston, Texas, 77026, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas, M.D. Anderson

    RECRUITING

    Houston, Texas, 77030, United States

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