UMIN試験ID | UMIN000005206 |
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受付番号 | R000006186 |
科学的試験名 | |
一般公開日(本登録希望日) | 2011/03/09 |
最終更新日 | 2012/01/06 04:50:56 |
日本語
英語
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products
日本語
英語
SPOT (Safety of Products using Optical Technologies)
日本語
英語
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products
日本語
英語
SPOT (Safety of Products using Optical Technologies)
北米/North America |
日本語
英語
Safety of vaginal products used to prevent HIV/STDs
感染症内科学/Infectious disease | 産婦人科学/Obstetrics and Gynecology |
成人/Adult |
悪性腫瘍以外/Others
いいえ/NO
日本語
英語
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.
その他/Others
日本語
英語
Evaluate the use of a new method to determine safety of vaginal products
探索的/Exploratory
説明的/Explanatory
該当せず/Not applicable
日本語
英語
The primary endpoint is the score obtained for colposcopy and OCT for the cervix and vagina at Visit 2 compared to Visit 1.
日本語
英語
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
二重盲検/Double blind -all involved are blinded
プラセボ・シャム対照/Placebo
いいえ/NO
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
封筒法/Numbered container method
2
教育・カウンセリング・トレーニング/Educational,Counseling,Training
医薬品/Medicine | 医療器具・機器/Device,equipment |
日本語
英語
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.
日本語
英語
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.
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
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日本語
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18 | 歳/years-old | 以上/<= |
45 | 歳/years-old | 以下/>= |
女/Female
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英語
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)
日本語
英語
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
30
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | |
ミドルネーム | |
姓 | Kathleen L. Vincent, M.D. |
日本語
英語
University of Texas Medical Branch, Galveston, Texas, USA
日本語
英語
Department of Ob/Gyn
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英語
301 University Blvd, Galveston, Texas 77555-0587, USA
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | |
ミドルネーム | |
姓 | Kathleen L. Vincent, M.D. |
日本語
英語
University of Texas Medical Branch, Galveston, Texas, USA
日本語
英語
Department of Ob/Gyn
日本語
英語
日本語
その他
英語
Starpharma, Melbourne, Australia
日本語
日本語
日本語
英語
日本語
その他
英語
National Institutes of Health
日本語
日本語
海外/Outside Japan
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英語
USA
日本語
英語
日本語
英語
日本語
英語
日本語
英語
いいえ/NO
日本語
英語
日本語
英語
University of Texas Medical Branch, Galveston, Texas, USA
2011 | 年 | 03 | 月 | 09 | 日 |
最終結果が公表されている/Published
http://www.ncbi.nlm.nih.gov/pubmed/22105265
日本語
英語
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.
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試験終了/Completed
2008 | 年 | 09 | 月 | 03 | 日 |
2009 | 年 | 02 | 月 | 01 | 日 |
2010 | 年 | 04 | 月 | 01 | 日 |
2010 | 年 | 08 | 月 | 01 | 日 |
2010 | 年 | 08 | 月 | 01 | 日 |
2011 | 年 | 08 | 月 | 01 | 日 |
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2011 | 年 | 03 | 月 | 07 | 日 |
2012 | 年 | 01 | 月 | 06 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006186
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006186
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