endometriosis
Conditions
Interventions
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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with clinically significant changes (calculation item) 1.Severest pelvic pain (lower abdominal pain / back pain) 2.Percentage of subjects for whom treatment is effective (calculation item) 3.Pelvic pain (lower abdominal pain / back pain) during menstruation or withdrawal bleeding 4.Pelvic pain (lower abdominal pain / back pain) except during menstruation or withdrawal bleeding 5.Coital pain 6.Defecation pain 7.Pelvic pain (lower abdominal pain / back pain) except coital pain and defecation pain 8.Pelvic pain (lower abdominal pain / back pain) that always felt and long lasting 9.Pelvic pain (lower abdominal pain / back pain) that develops suddenly and disappears in a short period of time 10.Average pain (calculation item) 11.Number of days in pain (calculation item) 12.Dysmenorrhea score 13.Concretion of Douglas' pouch 14.Limitation of uterine mobility 15.Pelvis tenderness 16.Number and size of chocolate cyst 17.Uterine size 18.Serum CA125 concentration 19.Serum IGF-1 concentration 20.Serum E2 concentration 21.Serum Progesterone concentration 22.Serum FSH concentration 23.Serum LH concentration 24.Serum Prolactin concentration 25.Endometrial thickness 26.Use of analgesics 27.Obstacles to daily activities 28.Obstacles to sleeping 29.PSQI 30.Obstacles to labor productivity 31.Clinical general improvement 32.Clinical general satisfaction 33.MRI evaluation of endometriosis 34.MRI evaluation of other associated lesions | — |
Contacts
Public ContactToshiaki Takayanagi
Fuji Pharma Co., Ltd.
Outcome results
None listed