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Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects

Phase 1
18 Years
45 Years
Not Enrolling
Uterine Cervical Dysplasia

Thank you

Trial Information

Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects

Inclusion Criteria:

- Between the ages of 18-45 years of age at enrollment

- Currently using a reliable birth control method (oral contraceptive pills,
DepoProvera or permanent sterilization)

- Able to provide written informed consent

- Provide male partner notification letter

- Have a Pap test negative pap (no cervical intraepithelial lesions) within 45 days
prior to screening

- Have regular monthly menses (every 21-35 days) or amenorrhea due to hormonal
contraceptive use

- Agree to undergo pelvic exam and colposcopy per protocol

- Able and willing to complete Study Diary

- Agree to wear condoms during all acts of vaginal intercourse or abstain from vaginal
intercourse during the 14 days

- Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit

- Agree to insert curcumin gelatin capsules as required per protocol

- Agree to abstain from nonsteroidal anti-inflammatory drugs (NSAIDS) during the 14

- Agree to abstain from all products containing curcumin or food consumption of
curcumin during the 14 days

- Agree to abstain from the following activities for at least 48 hours prior to
enrollment through the Day 14 visit:insertion of objects into the vagina except for a
penis, receiving oral or anal sex,using a diaphragm, cervical cap, female condom, or
vaginal contraceptive ring,using vaginal products other than the study gelatin
capsules, including douches, lubricants, spermicide or feminine hygiene
products,participating in other vaginal cream or contraceptive studies

- Agree to testing for HIV status via enzyme immunoassay (EIA)/Western Blot

Exclusion Criteria:

- Are post-menopausal

- Have had a hysterectomy with removal of the cervix

- Have a clinically significant chronic medical condition that is considered
progressive, including: coronary disease, congestive heart failure, chronic
obstructive lung disease, diabetes mellitus, chronic renal disease, active peptic
ulcer disease, chronic hepatic disease, multiple sclerosis, seizure disorder
requiring medication, and a coagulation or platelet disorder. Chronic nonprogressive
or intermittent syndromes are not excluded, including migraine headaches, mild
reactive airways disease, controlled hypertension, stable pain syndromes, or benign
gastric reflux.

- Have an intrauterine device (IUD) as a form of birth control

- Have any history of malignancy or current (within 45 days of screening) pap with
cervical intraepithelial lesions.

- Currently has documented lacerations on visual inspection present on the cervix,
vagina, vulva or perineum.

- Are pregnant or planning to become pregnant in the next three months

- Are currently breastfeeding

- Have a history of sensitivity or allergy to any compound used in this study

- Have Grade 2 or higher renal or hematologic abnormality, as defined by the Table for
Grading the Severity of Adult Adverse Events or at screening have a positive
bacterial urine culture. Women with a positive bacterial urine culture at screening
will be allowed to enroll after appropriate treatment if repeat evaluation is normal.

- In the three months prior to enrollment have had any of the following:Treatment for
Cervical disease or any other gynecologic surgery,A pregnancy or an abortion, An
IUD,Breakthrough menstrual bleeding or vaginal bleeding during or following vaginal

- Signs, as seen on pelvic exam at screening, consistent with an STD including
vaginitis, cervicitis or genital ulcers

- Signs, as seen on pelvic exam, of genital trauma

- Signs of genital tract infection from laboratory evaluations. Women with Candida
vaginitis or bacterial vaginosis at screening will be allowed to enroll after
appropriate treatment and if repeat evaluation is normal.

- In the three months prior to enrollment have had any of the following:History of
treatment for or a diagnosis with a new STD,Genital herpes simplex virus infection or
outbreak,Exchanged sex for money, drugs or gifts

- Are currently using, or in the last year have used intravenous drugs (except for
therapeutic use), cocaine or other recreational drugs, abused alcohol defined as
alcohol use that has required hospital admission for detoxification and therapy.

- Have any other condition that in the opinion of the investigator might interfere with
the evaluation of the study objectives.

- HIV positive

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is to reach the maximum selected dose (MSD) or maximum tolerated dose (MTD) of intravaginal curcumin among Pap test negative women without causing a dose-limiting toxicity.

Outcome Time Frame:

14 days

Safety Issue:


Principal Investigator

Lisa Flowers, Medical

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Uterine Cervical Dysplasia
  • chemoprevention
  • curcumin
  • pharmacokinetics
  • safety
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia



Emory University Atlanta, Georgia  30322