Topical Curcumin for HPV Related Cervical Disease

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Neoplasm Cervix
Interventions
DRUG

Curcumin C3 Complex

"Curcumin (Curcumin C3 Complex prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventative and therapeutic benefits.~Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.~Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes."

DRUG

Placebo

"Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.~Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes."

Trial Locations (3)

30303

Emory University, Atlanta

Grady Memorial Hospital, Atlanta

30308

Grady Hospital - Ponce De Leon Clinic, Atlanta

All Listed Sponsors
lead

Lisa Flowers

OTHER