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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005206
Receipt No. 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

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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 Obsterics 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
Email

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
Email

Sponsor
Institute Starpharma, Melbourne, Australia
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006186

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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