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Trial record 48 of 167 for:    curcumin

Trial on Safety and Pharmacokinetics of Intravaginal Curcumin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01035580
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Lisa Flowers, Emory University

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE December 18, 2009
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01035580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
Official Title  ICMJE Phase I Trial on Safety and Pharmacokinetics of Intravaginal Curcumin in Normal Female Subjects
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Cervical Dysplasia
Intervention  ICMJE
  • Drug: Curcumin
    Curcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg
  • Drug: curcumin
    all patients received the drug
    Other Name: Sabinsa Curcumin Capsules
Study Arms  ICMJE Experimental: curcurim
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.
Interventions:
  • Drug: Curcumin
  • Drug: curcumin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
13
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2009)
16
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01035580
Other Study ID Numbers  ICMJE IRB00020139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Flowers, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Flowers, Medical Emory University
PRS Account Emory University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP