臨床研究等提出・公開システム

Date of registration	June. 25, 2019
Last modified on	Nov. 10, 2021
Trial ID	jRCT2080224750

Scientific Title
Public Title

Completion Date or Terminated date	Nov. 05, 2020
Actual Enrolled Number	961
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	July. 21, 2021
URL hyperlink(s) related to results and publications	https://clinicaltrials.gov/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRFVSKCRFR4VA6h9Ei4L3BUgWwNG0it.

Plan to share IPD	Yes
Plan description	According to the Novo Nordisk disclosure commitment on novonordisk-trials.com URL: http://novonordisk-trials.com
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Novo Nordisk Pharma Ltd.
	Address	-
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Novo Nordisk Pharma Ltd.
	Address	-
	Phone Number	-
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		June. 19, 2019
Target Sample Size		50
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy
Secondary Outcome		efficacy

Primary Sponsor	Novo Nordisk Pharma Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB
Address of IRB
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	May. 17, 2019

Secondary ID No.	NCT03989232
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194827
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Nov. 10, 2021	(this page)	Changes
3	Nov. 25, 2020	Detail	Changes
2	June. 11, 2020	Detail	Changes
1	June. 25, 2019	Detail

List of change history