NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2011210027

Registered date:06/08/2021

A study of FSN-013 in Japanese patients with endometriosis

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedendometriosis
Date of first enrollment02/08/2021
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)Each subject will receive one tablet of FSN-013(Estetrol Hydrate/Drospirenone) or Placebo orally once a day.

Outcome(s)

Primary OutcomeThe amount of change in the most severe pelvic pain (lower abdominal pain / back pain)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1.Diagnosed as endometriosis by laparotomy or laparoscopy 2.Diagnosed as endometriosis (having ovarian chocolate cysts) by TVUS or MRI 3.Patients clinically diagnosed as endometriosis with any of Douglas fossa induration or limited uterine mobility or pelvic tenderness by vaginal or rectal examination 4.Aged >= 20 years at the time of informed consent 5.BMI < 30 kg/m2
Exclude criteria1.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

Contact

Public contact
Name Toshiaki Takayanagi
Address 5-7 Sanban-cho, Chiyoda-ku, Tokyo Tokyo Japan 102-0075
Telephone +81-3-3556-3344
E-mail clinical_trials@fujipharma.jp
Affiliation Fuji Pharma Co., Ltd.
Scientific contact
Name Toshiaki Takayanagi
Address 5-7 Sanban-cho, Chiyoda-ku, Tokyo Tokyo Japan 102-0075
Telephone +81-3-3556-3344
E-mail clinical_trials@fujipharma.jp
Affiliation Fuji Pharma Co., Ltd.