臨床研究等提出・公開システム

Date of registration	Feb. 27, 2020
Last modified on	Dec. 27, 2021
Trial ID	jRCT2080225090

Scientific Title	An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patients
Public Title	An open label, parallel group study to explore pharmacodynamics, pharmacokinetics and safety during 3 cyclic treatments of FSN-013 (E4/DRSP) in Japanese endometriosis patients

Completion Date or Terminated date	Sept. 30, 2021
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	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	Fuji pharma Co., Ltd
	Address	5-7, Sanban-cho, Chiyoda-ku, Tokyo, Japan
	Phone Number	+81-3-6862-5566
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Fuji pharma Co., Ltd
	Address	5-7, Sanban-cho, Chiyoda-ku, Tokyo, Japan
	Phone Number	+81-3-6862-5566
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		April. 22, 2020
Target Sample Size		80
Study Type		Interventional
Study Design	Study Design	multi-center, open-label, randomized, parallel group
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Japanese patients, diagnosed as endometriosis by laparotomy/laparoscopy, and/or as having ovarian chocolate cysts by TVUS or MRI 2. Aged >= 20 and < 50 years 3.BMI < 30 kg/m2
	Exclusion Criteria	1. Undiagnosed abnormal vaginal bleeding 6 months before the screening tests 2. Aged >= 40 years with ovarian chocolate cyst for which the largest diameter was > 10 cm 3. Ovarian chocolate cyst containing solid components 4. Had undergone surgical treatment for endometriosis by cyst puncture (such as transvaginal alcohol fixation), laparotomy, or laparoscopy (laparoscopy) within 2 months prior to the screening tests
	Minimum Age	20age old over
	Maximum Age	49age old under
	Gender	Female
Health Condition or Problem Studied		endometriosis
Intervention(s)		investigational material(s) Generic name etc : FSN-013 INN of investigational material : Estetrol/Drospirenone Therapeutic category code : 248 Mixed hormone preparations Dosage and Administration for Investigational material : oral dose control material(s) Generic name etc : Drospirenone/Ethinylestradiol Betadex INN of investigational material : Drospirenone/Ethinylestradiol Betadex Therapeutic category code : 248 Mixed hormone preparations Dosage and Administration for Investigational material : oral dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacodynamics Severest pelvic pain (VAS)
Secondary Outcome		safety exploratory pharmacokinetics pharmacodynamics Gynecological examination Hemostasis and related parameters Endocrine parameters

Primary Sponsor	Fuji Pharma Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	Fuji Pharma Co., Ltd.
Name of Research Funding	-

Name of IRB	IHL Shinagawa East One Medical Clinic IRB
Address of IRB	2-16-1, Konan, Minato-ku, Tokyo, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 13, 2020

Secondary ID No.	JapicCTI-205185
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Dec. 27, 2021	(this page)	Changes
3	June. 11, 2021	Detail	Changes
2	Feb. 17, 2021	Detail	Changes
1	Feb. 28, 2020	Detail

List of change history