臨床研究等提出・公開システム

Date of registration	April. 18, 2019
Last modified on	Mar. 31, 2022
Trial ID	jRCT2080224650

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Sept. 28, 2020
Actual Enrolled Number	335
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	Mar. 01, 2022
URL hyperlink(s) related to results and publications	https://www.sciencedirect.com/science/article/pii/S0015028221022147

Plan to share IPD	No
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	aska-clinical@aska-pharma.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	-
	Address	-
	Phone Number	-
	E-mail Address	aska-clinical@aska-pharma.co.jp

Recruitment Status	completed

Date of First Enrolment		May. 08, 2019
Target Sample Size		320
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	Female
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : relugolix 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 : leuprorelin Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy confirmatory -
Secondary Outcome		efficacy -

Primary Sponsor	-
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	Mar. 29, 2019

Secondary ID No.	NCT03931915
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194722
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Mar. 31, 2022	(this page)	Changes
5	June. 30, 2021	Detail	Changes
4	Dec. 10, 2020	Detail	Changes
3	Feb. 28, 2020	Detail	Changes
2	July. 03, 2019	Detail	Changes
1	May. 03, 2019	Detail

List of change history