UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Title of the study (Brief title)	Intracavernous injections of prostaglandin E1 for erectile dysfunction:multicenter study
Region	Japan

Condition
Condition	Erectile Dysfunction
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess intracavernous injections of prostaglandin E1 for erectile dysfunction at multicenter study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety and efficacy of intracavernous injections of prostaglandin E1
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	prostaglandin E1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) Obtaining of written informed consent 2) contraindication or unavailable of Phosophodiesterase5 inhibitor 3) Patienthad a good responce of PGE1-ICI
Key exclusion criteria	1) cases with diseases of dementia or mental disease 2) cases with past history of allergic reaction to medicine 3)Patients was deemed by the physician as inappropriate to attend. 4) priapism(past history, drepanocyte, eukemia,multiple myeloma )
Target sample size	200

Research contact person
Name of lead principal investigator	Atsushi Nagai
Organization	Kawasaki medical school
Division name	Department of Urology
Address	577 Matsushima Kurashiki, Okayama, Japan
TEL	086-462-1111
Email	nagai@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Atsushi Nagai
Organization	Kawasaki medical school
Division name	Department of Urology
Address	577 Matsushima Kurashiki, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	nagai@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Urology, Kawasaki medical school
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	長野赤十字病院（長野県） あらき腎・泌尿器科クリニック（岡山県） 岡山市立市民病院（岡山県） 聖隷浜松病院（静岡県） 慈愛会今村病院（鹿児島県） 名古屋市立大学（愛知県） 高松赤十字病院（香川県） 大阪市立大（大阪府） 中部労災病院（愛知県） 札幌医科大学（北海道） 獨協医科大学越谷病院（埼玉県） 昭和大学藤が丘病院（神奈川県） 三樹会病院（北海道） 順天堂大学浦安病院（千葉県） 筑波大学（茨城県） 原三信病院（福岡県） 大阪大学（大阪府） 東邦大学リプロダクションセンター（東京都） 東邦大学（東京都） 順天堂大学（東京都） 北海道済生会小樽病院（北海道） 平塚市民病院（神奈川県） 東京歯科大学市川総合病院（千葉県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 25 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014497