A study of FSN-013 in Japanese patients with dysmenorrhea

JRCT ID: jRCT2011210023

Registered date:28/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: dysmenorrhea
• Date of first enrollment: 02/08/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): FSN-013 or Placebo administered orally

Outcome(s)

• Primary Outcome: The amount of change in the total dysmenorrhea score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.Secondary dysmenorrhea
-Diagnosed as Endometriosis or Adenomyosis by laparotomy or laparoscopy
-Diagnosed as Endometriosis with ovarian chocolate cysts or Adenomyosis or Uterine fibroids by TVUS or MRI
2.Functional dysmenorrhea
-Patients whose secondary dysmenorrhea was ruled out by history taking, vaginal examination, and TVUS, etc.
3.Aged >= 20 years at the time of informed consent
4.BMI < 30 kg/m2

Exclude 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

Related Information

• Primary Sponsor: Takayanagi Toshiaki
• Source(s) of Monetary Support: M3, Inc.