Topical Curcumin for HPV Related Cervical Disease (NCT04266275) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Topical Curcumin for HPV Related Cervical Disease
United States200 participantsStarted 2027-04
Plain-language summary
The purpose of this study is to see if curcumin can suppress HPV infection in women with low-grade squamous intraepithelial lesions (LSIL) disease or treated high-grade squamous intraepithelial lesions (HSIL) disease. This study plans to explore the effect of curcumin as a potential medical treatment in HIV-uninfected and infected women with mild precancerous lesions of the cervix or recently treated high-grade precancerous lesions at risk for persistent HPV infection. About 200 women with low-grade precancerous lesions of the cervix or recently treated high-grade precancerous lesions will be enrolled to either insert 2000 mg of curcumin capsules in their vagina once a week or placebo after undergoing colposcopy or loop electrosurgical excision procedure (LEEP). They will have a repeat visit in 6 months where they will undergo a Pap smear and HPV test to determine if there are higher rates of HPV clearance after curcumin administration. If HPV is present or the Pap smear is abnormal, patients will then undergo colposcopic examination to evaluate cervical histology.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-uninfected and infected women (without current AIDS-defining illness)
* Presence of a cervix
* Biopsy-proven LSIL disease or recently treated HSIL disease
* Adherence to combined anti-retrovirals (cART) if HIV infected
* On continuous antiretrovirals with a cluster of differentiation 4 (CD4) count \>200 cells/ml with sustained undetectable viral load for at least 3 months (only for HIV-positive participants)
* On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot)
* Willing to conform to the study requirements
* Reliable follow-up and contact information
* No risk factors for HSIL or microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
* For women with HSIL only, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing
Exclusion Criteria:
* Untreated HSIL or invasive features on colposcopy and the biopsy specimen
* Not adherent to anti-retroviral therapy (cART) (HIV infected participants)
* CD4 count =\<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants)
* Lactating and pregnant people
* Patient with irregular cycles (more than once a month)
* Not on reliable birth control.
* Previous hysterectomy
* Prior diagnosis of cervical cancer, treated or untreated
* Inabil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.