臨床研究等提出・公開システム

Date of registration	Sept. 02, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080223310

Scientific Title	Administration study to healthy adult male as part of reserch toward the development of detection method for testosterone doping
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	LSI Mededience Coporation
	Address	+81-3-5994-2351
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		10
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Sex:Male Age:20 or more years old, less than 35 years old. BMI The weight (kg) / height (m) 2 :18.5 or more and less than 25.0(at the time of a prior inspection). There is consent to clinical test participation.
	Exclusion Criteria	1.Hypersensitivity to sesami oil and drugs, 2.A history of alcohol or drug addiction, 3.Under the medical treatment or it may treatof a certain disease, 4.Ethical or OTC pharmaceuticals administered within two weeks before scheduled administation of the study drug, Supplement, grapefruit or its products, or foods cotaing Western St. John's comsumed within one week before scheduled administation of the study drug, 5.Not less than 200mL of blood is collected within 30 days or not less than 400mL of blood is collected within 90 days before scheduled administation of the study drug, 6.Weight : less than 50kg(at the time of a prior inspection), 7.A person shall not have a schedule of consultation of another hospital until this administration study, 8.A person shall not have possibility of prostatic hypertrophy, heart disease, kidny disease or medical histrory, 9.A person judged unfit of this study by responsible doctor
	Minimum Age	20age old over
	Maximum Age	35age old under
	Gender	Male
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : Enarmon depot intramuscular injection 125mg INN of investigational material : Therapeutic category code : 246 Androgen preparations Dosage and Administration for Investigational material : Intramuscular injection 100mg/once
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	LSI Medience Corporation
Secondary Sponsor

Name of Funding Organization	Japan Anti Doping Agency
Name of Research Funding

Name of Funding Organization
Name of Research Funding	Japan Sports Agency grant

Name	Medical corporation Shinanokai Shinanozaka Clinic
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-163365
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Mar. 27, 2018	Detail	Changes
5	Sept. 11, 2017	Detail	Changes
4	Sept. 11, 2017	Detail	Changes
3	Sept. 20, 2016	Detail	Changes
2	Sept. 20, 2016	Detail	Changes
1	Sept. 02, 2016	Detail

List of change history