UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005206 |
|---|---|
| Receipt number | R000006186 |
| Scientific Title | Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products |
| Date of disclosure of the study information | 2011/03/09 |
| Last modified on | 2012/01/06 04:50:56 |
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Basic information
Public title
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products
Acronym
SPOT (Safety of Products using Optical Technologies)
Scientific Title
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products
Scientific Title:Acronym
SPOT (Safety of Products using Optical Technologies)
Region
| North America |
Condition
Condition
Safety of vaginal products used to prevent HIV/STDs
Classification by specialty
| Infectious disease | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether regular use of an over-the-counter formulation of N-9 will result in epithelial toxicity detectable by OCT but not by colposcopy.
Basic objectives2
Others
Basic objectives -Others
Evaluate the use of a new method to determine safety of vaginal products
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the score obtained for colposcopy and OCT for the cervix and vagina at Visit 2 compared to Visit 1.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
10 women were randomized to use placebo vaginal gel twice daily for 5.5 days. The vagina and cervix were examined using standard colposcopy and a new method, OCT, to determine the ability of OCT to detect vaginal/cervical findings not detected by colposcopy.
Interventions/Control_2
20 women were randomized to use the over-the-counter spermicide N-9 as a vaginal gel twice daily for 5.5 days. The vagina and cervix were examined using standard colposcopy and a new method, OCT, to determine the ability of OCT to detect vaginal/cervical findings not detected by colposcopy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Provides written informed consent
2. Healthy female, 18-45 years of age
3. Pre-menopausal as defined by still having regular menstrual cycles and under age 46 years
4. Willing to discontinue use of vaginal products such as douches, drying agents, vaginal moisturizers, spermicides, tampons, and deodorant pads for 48 hours prior to their appointment and until completion of the study (i.e., from Day -2 to Day 13)
5. Willing to abstain from intercourse for 48 hours prior to Visit 1 until completion of the study (i.e., from Day -2 to Day 13)
Key exclusion criteria
1. History of hysterectomy
2. Gynecologic surgery within the last year
3. History of sensitivity/allergy to any component of the study products, sexual lubricants, spermicides containing Nonoxynol-9, or similar products
4. Current vaginal, cervical, or bladder symptoms such as irritation, burning, itching
5. Current genital pain or discomfort
6. Currently pregnant or within two calendar months from the last pregnancy outcome (delivery, spontaneous abortion, induced abortion)
7. Currently breast-feeding
8. Positive urine pregnancy test
9. Known history of HIV infection
10. Have been diagnosed with any STIs in the 3 months prior to the screening visit or at the screening visit
11. Any evidence of an acute vaginal infection or STI
12. Abnormal Pap smear at screening visit
13. Currently using, or suspected to be using, injection drugs
14. Current use of a vaginal ring or intrauterine device (IUD)
15. Antibiotic use in the two weeks prior to Visit 1
16. Chronic systemic steroid use (does not exclude the use of topical or inhaled steroids)
17. Current diagnosis of cervical cancer or pre-cancer cells
18. Excessive irregular menstrual or inter-menstrual bleeding or unpredictable bleeding pattern (this would interfere with scheduling study visits at a time free from bleeding)
19. Has received an investigational product within 30 days or 5 half-lives (whichever is the longer)
20. Participant has knowledge that her partner is currently having a sexual relationship(s) with another person (male or female)
21. Participant has knowledge that her current partner(s):
a. Has a history of HIV infection
b. Had an STD within the last 6 months
c. Is currently using, or is suspected to be using, injection drugs
22. Participant, in the opinion of the investigator, should not participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kathleen L. Vincent, M.D. |
Organization
University of Texas Medical Branch, Galveston, Texas, USA
Division name
Department of Ob/Gyn
Zip code
Address
301 University Blvd, Galveston, Texas 77555-0587, USA
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kathleen L. Vincent, M.D. |
Organization
University of Texas Medical Branch, Galveston, Texas, USA
Division name
Department of Ob/Gyn
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Starpharma, Melbourne, Australia
Institute
Department
Personal name
Funding Source
Organization
National Institutes of Health
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University of Texas Medical Branch, Galveston, Texas, USA
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22105265
Number of participants that the trial has enrolled
Results
Vincent KL, Stanberry LR, Moench TR, Breitkopf CR, Loza ML, Wei J, Grady J, Paull J, Motamedi M, Rosenthal SL. Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1354-61.
Results: Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02).
CONCLUSION: Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 07 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006186
