Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study
- Conditions
- endometriosis (ovarian endometrioma)
- Registration Number
- JPRN-UMIN000020865
- Lead Sponsor
- Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 120
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.