Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
Primary Purpose
Uterine Cervical Dysplasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Curcumin
curcumin
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Dysplasia focused on measuring chemoprevention, curcumin, pharmacokinetics, safety
Eligibility Criteria
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 days
- 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 intercourse
- 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
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
curcurim
Arm Description
This was a 3 + 3 dose escalation trial starting at 500 mg of cur cumin capsules administered daily intravaginally for 14 days. The dose increased after safety was demonstrated in 3 subjects by 500 mg up to a max of 2000 mgs.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01035580
Brief Title
Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
Official Title
Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to determine the maximum tolerable dose and safety of intravaginal curcumin in a normal population of women (women with no evidence of cervical cytological abnormalities by pap testing).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
chemoprevention, curcumin, pharmacokinetics, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
curcurim
Arm Type
Experimental
Arm Description
This was a 3 + 3 dose escalation trial starting at 500 mg of cur cumin capsules administered daily intravaginally for 14 days. The dose increased after safety was demonstrated in 3 subjects by 500 mg up to a max of 2000 mgs.
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
Curcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg
Intervention Type
Drug
Intervention Name(s)
curcumin
Other Intervention Name(s)
Sabinsa Curcumin Capsules
Intervention Description
all patients received the drug
Primary Outcome Measure Information:
Title
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.
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 days
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 intercourse
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Flowers, Medical
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
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