A dose determination study of NS-580 in patients with endometriosis (late phase II)

JRCT ID: jRCT2031210685

Registered date:22/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: endometriosis
• Date of first enrollment: 22/04/2022
• Target sample size: 372
• Study type: Interventional
• Intervention(s): Each participant will receive one of three oral doses (50 mg, 100 mg, 150 mg) of NS-580 or placebo twice daily over a 24-week intervention period.

Outcome(s)

• Primary Outcome: pelvic pain

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 49age old
• Gender: Female

Include criteria

-Patients who are clinically diagnosed with endometriosis
-Patients whose severity of pelvic pain caused by endometriosis meets selection criteria
-Patients with regular menstrual cycle
-Patients aged 20 years or older and 49 years or younger (at the time of informed consent)

Exclude criteria

-Patients for whom surgical treatment of organic diseases is considered to be prioritized by the investigator or subinvestigator
-Patients aged 40 years or older (at the time of consent) with a longest diameter of ovarian chocolate cyst exceeding 10cm
-Patients with solid image in ovarian chocolate cyst

Related Information

• Primary Sponsor: Higashioka Masaya