臨床研究等提出・公開システム

Japanese

Date of registration	May. 11, 2021
Last modified on	May. 09, 2023
Trial ID	jRCTs041210016

Scientific Title	A randomized, open-label, parallel-group controlled trial investigating the efficacy and safety of long-term low-dose Dienogest in patients with dysmenorrhea due to endometriosis
Public Title	The efficacy and safety of long-term low-dose Dienogest in patients with dysmenorrhea due to endometriosis.

Contact for Scientific Queries	Name	Kikuno Kyoko
	Affiliation	Gifu University Hospital
	Address	1-1 Yanagido Gifu,Gifu
	Telephone	+81-58-230-6000
	E-mail	d6627@gifu-u.ac.jp
Contact for Public Queries	Name	Kikuno Kyoko
	Affiliation	Gifu University Hospital
	Address	1-1 Yanagido Gifu,Gifu
	Telephone	+81-58-230-6000
	E-mail	d6627@gifu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 11, 2021
Actual date of first enrollment		Aug. 13, 2021
Target sample size		88
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients who have been diagnosed with endometriosis (ovarian endometriotic cyst) and do not plan to undergo surgery 2. Patients with dysmenorrhea 3. Patients who plan to continue using Dienogest for more than 48 weeks. 4.Patients over 20years old to premenopausal at the time of consent 5.Patients who have written consent to participate in this study
	Exclusion Criteria	1.Patients who have been diagnosed with endometriosis (ovarian endometriotic cyst) and do not plan to undergo surgery 2. Patients with dysmenorrhea 3. Patients who plan to continue using Dienogest for more than 48 weeks. 4.Patients over 20years old to premenopausal at the time of consent 5.Patients who have written consent to participate in this study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		dysmenorrhea due to endometriosis
Intervention(s)		0.5 mg group: Dienogest 0.5 mg twice daily, 1 tablet at a time for 48 weeks. 1 mg group: Dienogest 1 mg twice daily, 1 tablet at a time for 48 weeks.
Health Condition(s) Keyword		endometriosis dysmenorrhea
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Changes in VAS 48 weeks after baseline administration
Secondary Outcome(s)		1. Incidence of low estrogen symptoms during reserch treatment(quantified using menopausal score) 2. Changes in dysmenorrhea score 48 weeks after dosing from baseline 3. Changes in menopausal score 48 weeks after dosing from baseline 4. Rate of reduction in ovarian endometriotic cyst size 48 weeks after baseline administration 5. Change in bone mineral density 48 weeks after administration from baseline 6. Primary endopoints and secondary endopoints above at 12,24,and 36 weeks.

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	MOCHIDA PHARMACEUTICAL CO., LTD.
Secondary Sponsor	Applicable

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	1,Kawasumi,Mizuhocho,Mizuhoku,Nagoya,Aichi, Aichi
Telephone	+81-52-858-7215
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	Feb. 24, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	May. 09, 2023	(this page)	Changes
6	Feb. 06, 2023	Detail	Changes
5	Jan. 27, 2023	Detail	Changes
4	Sept. 12, 2022	Detail	Changes
3	July. 15, 2022	Detail	Changes
2	Jan. 11, 2022	Detail	Changes
1	May. 11, 2021	Detail

List of change history