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利用者名:
UMIN ID:

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000036225
受付番号 R000041269
科学的試験名
一般公開日(本登録希望日) 2019/06/19
最終更新日 2021/02/02

※ 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
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
一般向け試験名略称/Acronym
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
科学的試験名/Scientific Title
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
科学的試験名略称/Scientific Title:Acronym
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
試験実施地域/Region
アフリカ/Africa

対象疾患/Condition
対象疾患名/Condition
sexual dysfunction
疾患区分1/Classification by specialty
泌尿器科学/Urology
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
We aimed in our study to evaluate the impact of atorvastatin therapy against adapting healthy life style program on sexual function in young women with high cholesterol levels as well as ambulatory blood pressure and lipids profile.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
We aimed in our study to evaluate the impact of atorvastatin therapy against adapting healthy life style program on sexual function in young women with high cholesterol levels as well as ambulatory blood pressure and lipids profile.
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
lowering of lipids profile and ambulatory blood pressure
副次アウトカム評価項目/Key secondary outcomes
improvement of female sexual function

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 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
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 中央登録/Central registration

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1
30 patients received atorvastat20-40 mg daily for 6 months (group A)
介入2/Interventions/Control_2
30 patients adapted healthy life style program for 6 months (group B)
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
25 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
females with hypercholestrolemia
除外基準/Key exclusion criteria
Any woman with chronic debilitating diseases, any past history of urogynecological operations were excluded from the study. Also, pregnant or lactating women or women who received systemic hormones as contraceptives or replacement therapy were excluded.
目標参加者数/Target sample size 60

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

ミドルネーム

sameh
ミドルネーム fayek GamalEl Din
Saleh
所属組織/Organization
Kasr Al-Ainy Faculty of medicine Cairo university
所属部署/Division name
Andrology & STDs
郵便番号/Zip code 202
住所/Address
El saray street El manial
電話/TEL 01227109309
Email/Email samehfayek@hotmail.com

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

sameh
ミドルネーム fayek GamalEl Din
Saleh
組織名/Organization
Kasr Al-Ainy Faculty of medicine Cairo university
部署名/Division name
Andrology & STDs
郵便番号/Zip code 202
住所/Address
El saray street El manial
電話/TEL 01227109309
試験のホームページURL/Homepage URL
Email/Email samehfayek@hotmail.com

実施責任組織/Sponsor
機関名/Institute その他 Beni Suef University Faculty of Medicine
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 Beni Suef University Faculty of Medicine
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 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


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
Beni Suef University, Faculty of medicine, Cairo, Egypt
住所/Address
Beni Suef, Egypt
電話/Tel 082 2356845
Email/Email nashaatnabil@windowslive.com

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

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
2019 06 19

関連情報/Related information
プロトコル掲載URL/URL releasing protocol Healthy life style is more effective than atorvastatin in improving sexual function
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications Healthy life style is more effective than atorvastatin in improving sexual function
組み入れ参加者数/Number of participants that the trial has enrolled 60
主な結果/Results
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
主な結果入力日/Results date posted
2021 02 02
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
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
参加者の流れ/Participant flow
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
有害事象/Adverse events
No adverse side effects were recorded
評価項目/Outcome measures
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
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 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2019 01 09
倫理委員会による承認日/Date of IRB
2019 01 09
登録・組入れ開始(予定)日/Anticipated trial start date
2019 03 01
フォロー終了(予定)日/Last follow-up date
2019 12 26
入力終了(予定)日/Date of closure to data entry
2019 12 26
データ固定(予定)日/Date trial data considered complete
2019 12 26
解析終了(予定)日/Date analysis concluded
2019 12 28

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
2019 03 16
最終更新日/Last modified on
2021 02 02


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=R000041269
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041269

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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