Uterine Cervical DysplasiaPhase 1NCT01035580
Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
A Phase 1 study testing Curcumin in people with Uterine Cervical Dysplasia, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects
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).
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- Curcumin
- Keywords
- chemoprevention, curcumin, pharmacokinetics, safety
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Curcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg
curcuminDrug
Also called Sabinsa Curcumin Capsules
all patients received the drug
| Study group | Role | What they receive |
|---|---|---|
| curcurim | Experimental | 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. Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Flowers, Emory University
- Investigators
- Lisa Flowers, Medical, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035580
- Sponsor's protocol ID
- IRB00020139
- Status last verified
- Nov 2013
- First submitted
- 17 Dec 2009
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects
- ClinicalTrials.gov ID
- NCT01035580
- Acronym / sponsor ID
- IRB00020139
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- chemoprevention, curcumin, pharmacokinetics, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| curcurim | Experimental | Drug: CurcuminThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg | Drug | curcurim |
| curcuminAlso: Sabinsa Curcumin Capsulesall patients received the drug | Drug | curcurim |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Flowers, Medical principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin in people with Uterine Cervical Dysplasia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.