臨床研究等提出・公開システム

Date of registration	Nov. 08, 2024
Last modified on	June. 25, 2025
Trial ID	jRCT2011240049

Scientific Title	Phase 2/3 study of MD-352 in patients with dysmenorrhoea
Public Title	Phase 2/3 study of MD-352 in patients with dysmenorrhoea

Contact for Scientific Queries	Name	Mori Takuya
	Affiliation	Mochida Pharmaceutical Co., Ltd.
	Address	7, Yotsuya 1-chome, Shinjuku-ku, Tokyo
	Telephone	+81-3-3225-6332
	E-mail	clinical.trials.contact@mochida.co.jp
Contact for Public Queries	Name	Public relations
	Affiliation	Mochida Pharmaceutical Co., Ltd.
	Address	7, Yotsuya 1-chome, Shinjuku-ku, Tokyo
	Telephone	+81-3-3225-6303
	E-mail	webmaster@mochida.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 01, 2024
Actual date of first enrollment		Dec. 11, 2024
Target sample size		285
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	-Patients diagnosed with primary dysmenorrhea or secondary dysmenorrhea. -Patients whose last two menstrual cycles prior to randomization enrollment each fall within a range of 30+/-5 days. -Patients who have a degree of 3 points or more of dysmenorrhea score during the menstrual cycle of the screening period.
	Exclusion Criteria	-Patients with a complication of lower abdominal pain or lumber pain the cause of which can not be ruled out as dysmenorrhea. -Patients with a complication or history of thrombophlebitis, pulmonary embolism, cerebral vascular disorder or coronary artery disease. Patients with a predisposing factor of thrombosis. -Patients who are pregnant or possibly pregnant or nursing mother, or patients who cannot comply with contraception during the study period.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Dysmenorrhea
Intervention(s)		MD-352 at A dose, at B dose or placebo is administered orally.
Primary Outcome(s)		Efficacy: Change in dysmenorrhea score Safety: Adverse events Genital haemorrhage
Secondary Outcome(s)		Efficacy: Change in VAS score for painful symptom (lower abdominal pain or lumber pain) Changes in pelvic pain (lower abdominal pain or lumber pain) score Safety: Adverse drug reactions

Primary Sponsor	Mochida Pharmaceutical Co., Ltd.

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	Nov. 12, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 25, 2025	(this page)	Changes
2	Dec. 13, 2024	Detail	Changes
1	Nov. 08, 2024	Detail

List of change history