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

JRCT ID: jRCT2011240049

Registered date:08/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Dysmenorrhea
• Date of first enrollment: 01/12/2024
• Target sample size: 285
• Study type: Interventional
• Intervention(s): MD-352 at A dose, at B dose or placebo is administered orally.

Outcome(s)

Primary Outcome

Efficacy:
Change in dysmenorrhea score
Safety:
Adverse events
Genital haemorrhage

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mori Takuya