UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products

一般向け試験名略称/Acronym

日本語

英語
SPOT (Safety of Products using Optical Technologies)

科学的試験名/Scientific Title

日本語

英語
Evaluation of Optical Coherence Tomography (OCT) as a Safety Tool for Assessment of Vaginal Products

科学的試験名略称/Scientific Title:Acronym

日本語

英語
SPOT (Safety of Products using Optical Technologies)

試験実施地域/Region

北米/North America

対象疾患名/Condition

日本語

英語
Safety of vaginal products used to prevent HIV/STDs

疾患区分1/Classification by specialty

感染症内科学/Infectious disease	産婦人科学/Obstetrics and Gynecology
成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

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.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語

英語
Evaluate the use of a new method to determine safety of vaginal products

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

説明的/Explanatory

試験のフェーズ/Developmental phase

該当せず/Not applicable

主要アウトカム評価項目/Primary outcomes

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.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

二重盲検/Double blind -all involved are blinded

コントロール/Control

プラセボ・シャム対照/Placebo

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

いいえ/NO

割付コードを知る方法/Concealment

封筒法/Numbered container method

群数/No. of arms

2

介入の目的/Purpose of intervention

教育・カウンセリング・トレーニング/Educational,Counseling,Training

介入の種類/Type of intervention

医薬品/Medicine	医療器具・機器/Device,equipment

介入1/Interventions/Control_1

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.

介入2/Interventions/Control_2

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.

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

45

歳/years-old

以下/>=

性別/Gender

女/Female

選択基準/Key inclusion criteria

日本語

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)

除外基準/Key exclusion criteria

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

目標参加者数/Target sample size

30

責任研究者/Name of lead principal investigator

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.

所属組織/Organization

日本語

英語
University of Texas Medical Branch, Galveston, Texas, USA

所属部署/Division name

日本語

英語
Department of Ob/Gyn

郵便番号/Zip code

住所/Address

日本語

英語
301 University Blvd, Galveston, Texas 77555-0587, USA

電話/TEL

Email/Email

試験問い合わせ窓口担当者/Name of contact person

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.

組織名/Organization

日本語

英語
University of Texas Medical Branch, Galveston, Texas, USA

部署名/Division name

日本語

英語
Department of Ob/Gyn

郵便番号/Zip code

住所/Address

日本語

英語

電話/TEL

試験のホームページURL/Homepage URL

Email/Email

機関名/Institute

日本語
その他

英語
Starpharma, Melbourne, Australia

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
National Institutes of Health

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語
USA

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語

住所/Address

日本語

英語

電話/Tel

Email/Email

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

University of Texas Medical Branch, Galveston, Texas, USA

一般公開日（本登録希望日）/Date of disclosure of the study information

2011

年

03

月

09

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22105265

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

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.

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2008

年

09

月

03

日

倫理委員会による承認日/Date of IRB

登録・組入れ開始（予定）日/Anticipated trial start date

2009

年

02

月

01

日

フォロー終了(予定)日/Last follow-up date

2010

年

04

月

01

日

入力終了(予定)日/Date of closure to data entry

2010

年

08

月

01

日

データ固定（予定）日/Date trial data considered complete

2010

年

08

月

01

日

解析終了(予定)日/Date analysis concluded

2011

年

08

月

01

日

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2011

年

03

月

07

日

最終更新日/Last modified on

2012

年

01

月

06

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000006186

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006186