endometriosis
Conditions
Interventions
Each subject will receive one tablet of FSN-013(Estetrol Hydrate/Drospirenone) or Placebo orally once a day.
Sponsors
Takayanagi Toshiaki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of change in the most severe pelvic pain (lower abdominal pain / back pain) | — |
Contacts
Public ContactToshiaki Takayanagi
Fuji Pharma Co., Ltd.
Outcome results
None listed