endometriosis (ovarian endometrioma)
Conditions
Interventions
dienogest 1mg twice a day (2mg/day) From menstrual cycle day 2-5 For 24 months
ultra low dose estrogen and progesterone tablet 1 tablet once a day (at the same time of each day) From menstrua
Sponsors
Osaka University Hospital
Minoh City Hospital Toyonaka Municipal Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (a) Patients who had undergone laparoscopic surgery for ovarian endometriomas at Osaka University Hospital, Minoh City Hospital or Toyonaka Municipal Hospital (b) Patients who consent to this study in writing (c) Patients who do not want to become pregnant during this study period (d) Patients more than 20 years old and not more than 50 years old
Exclusion criteria
Exclusion criteria: (a) undiagnosed genital bleeding (b) pregnant, probably pregnant or lactating (c) allergic to ingredient of dinagest tablets or LUNABELL tablets ULD (d) patients who want to become pregnant (e) estrogen dependent malignant tumor (e.g. breast cancer, endometrial cancer), cervical cancer or suspected to have those diseases (f) thrombophlebitis, pulmonary embolism, cerebrovascular accident and coronary artery disease, or past history of those diseases (g) more than 35 years old and smoke more than 15 cigarettes (h) migraine with aura (e.g. fortification spectrum etc.) (i) valvular disease with pulmonary; hypertension or atrial fibrillation valvular disease with past history of subacute infectious endocarditis (j) diabetes with vascular disease (diabetic nephropathy, diabetic retinopathy etc.) (k) primary cause of thrombosis (l) antiphospholipid antibody syndrome (m) within 4 weeks before surgery, within 2 weeks after surgery, within 4 weeks after delivery, or long-term bed rest (n) severe liver damage (o) liver tumor (p) lipid metabolism abnormality (q) hypertension (except mild hypertension) (r) otosclerosis (s) past history of jaundice, persistent pruritus or herpes during pregnancy (t) probably in the middle of bone growth (u) patients who are judged ineligible by doctor in charge for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the recurrence rate 2 years after surgery. The definition of recurrence is the presence of endometriomas more than 2 cm by transvaginal ultrasound on at least two consecutive examinations. Follow-up visits and transvaginal ultrasound are scheduled every 3 months after commencement of treatment. Pelvic MRI is performed when recurrence is suspected. | — |
Secondary
| Measure | Time frame |
|---|---|
| The patients are asked to score the intensity of pelvic pain at the follow-up visit using a visual analogue scale (VAS) score. Disease recurrence is defined as sequential increase of VAS score or increase of VAS score as high as preoperative score. | — |
Countries
Japan
Contacts
Public ContactMami Morikawa
Osaka University Graduate School of Medicine Department of Obstetrics and Gynecology
Outcome results
None listed