臨床研究等提出・公開システム

Date of registration	Aug. 06, 2021
Last modified on	Oct. 31, 2023
Trial ID	jRCT2011210027

Scientific Title	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Cyclic Oral Administration of FSN-013 (E4/DRSP) in Japanese Patients With Endometriosis
Public Title	A study of FSN-013 in Japanese patients with endometriosis

Contact for Scientific Queries	Name	Takayanagi Toshiaki
	Affiliation	Fuji Pharma Co., Ltd.
	Address	5-7 Sanban-cho, Chiyoda-ku, Tokyo
	Telephone	+81-3-3556-3344
	E-mail	clinical_trials@fujipharma.jp
Contact for Public Queries	Name	Takayanagi Toshiaki
	Affiliation	Fuji Pharma Co., Ltd.
	Address	5-7 Sanban-cho, Chiyoda-ku, Tokyo
	Telephone	+81-3-3556-3344
	E-mail	clinical_trials@fujipharma.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 02, 2021
Actual date of first enrollment		Aug. 02, 2021
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Diagnosed as endometriosis by laparotomy or laparoscopy 2.Diagnosed as endometriosis (having ovarian chocolate cysts) by TVUS or MRI 3.Patients clinically diagnosed as endometriosis with any of Douglas fossa induration or limited uterine mobility or pelvic tenderness by vaginal or rectal examination 4.Aged >= 20 years at the time of informed consent 5.BMI < 30 kg/m2
	Exclusion Criteria	1.Unconfirmed diagnosis of abnormal vaginal bleeding within 6 months before the screening tests 2.Aged >= 40 years with ovarian chocolate cysts for which the largest diameter was > 10 cm 3.Ovarian chocolate cysts containing solid components 4.Had undergone surgical treatment for endometriosis, adenomyosis and uterine fibroids by cyst puncture (such as transvaginal alcohol fixation), laparotomy or laparoscopy within 2 months before screening
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		endometriosis
Intervention(s)		Each subject will receive one tablet of FSN-013(Estetrol Hydrate/Drospirenone) or Placebo orally once a day.
Primary Outcome(s)		The amount of change in the most severe pelvic pain (lower abdominal pain / back pain)

Primary Sponsor	Fuji Pharma Co., Ltd.

Source of Monetary Support	M3, Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Sapporo Medical Association's IRB(Institutional Review Board)
Address	19-1-1 Odori Nishi Chuo-ku, Sapporo-shi, Hokkaido
Telephone	+81-11-611-4181
E-Mail	chiken@spmed.or.jp
Approval Status	Approval
Date of approval	July. 08, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Oct. 31, 2023	(this page)	Changes
3	June. 24, 2022	Detail	Changes
2	Aug. 13, 2021	Detail	Changes
1	Aug. 06, 2021	Detail

List of change history