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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000005206
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

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
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
SPOT (Safety of Products using Optical Technologies)
科学的試験名/Scientific Title
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
SPOT (Safety of Products using Optical Technologies)
試験実施地域/Region
北米/North America

対象疾患/Condition
対象疾患名/Condition
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/Obsterics 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/Objectives
目的1/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.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
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

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
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

介入/Intervention
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
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
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

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
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
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
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/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Kathleen L. Vincent, M.D.
所属組織/Organization
University of Texas Medical Branch, Galveston, Texas, USA
所属部署/Division name
Department of Ob/Gyn
郵便番号/Zip code
住所/Address
301 University Blvd, Galveston, Texas 77555-0587, USA
電話/TEL
Email/Email

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Kathleen L. Vincent, M.D.
組織名/Organization
University of Texas Medical Branch, Galveston, Texas, USA
部署名/Division name
Department of Ob/Gyn
郵便番号/Zip code
住所/Address

電話/TEL
試験のホームページURL/Homepage URL
Email/Email

実施責任組織/Sponsor
機関名/Institute その他 Starpharma, Melbourne, Australia
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 National Institutes of Health
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization
USA

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

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


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
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

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions University of Texas Medical Branch, Galveston, Texas, USA

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2011 03 09

関連情報/Related information
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/Result
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
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

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

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

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


試験進捗状況/Progress
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 09 03
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 02 01
フォロー終了(予定)日/Last follow-up date
2010 04 01
入力終了(予定)日/Date of closure to data entry
2010 08 01
データ固定(予定)日/Date trial data considered complete
2010 08 01
解析終了(予定)日/Date analysis concluded
2011 08 01

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2011 03 07
最終更新日/Last modified on
2012 01 06


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006186
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006186

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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