NIPH Clinical Trials Search

JRCT ID: jRCT1051190028

Registered date:26/06/2019


Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEndometriosis (ovarian endometrioma)
Date of first enrollment01/03/2017
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)Arm dienogest: oral dienogest 1mg twice a day from menstrual cycle day 2-5 for 24 months. Arm LUNABELL tablets ULD: oral LUNABELL 1 tablet once a day at the same time of each day from menstrual cycle day 2-5 for 24 months. After taking tablets for 21 days, patients stop it for 7 days. These 28 days is one cycle and patients start to take the tablet from cycle day 29.


Primary OutcomeThe recurrence rate 2 years of ovarian endometrioma after surgery
Secondary OutcomeThe 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.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 50age old
Include criteria1. Patients who had undergone laparoscopic surgery for ovarian endometrioma at Osaka University Hospital, Minoh City Hospital or Toyonaka Municipal Hospital 2. Patients who consent to this study in writing 3. Patients who do not want to become pregnant during this study period 4. Patients subject with more than 20 years old and not more than 50 years old
Exclude criteria1. undiagnosed genital bleeding 2. pregnant, probably pregnant or lactating 3. allergic to ingredient of dinagest tablets or LUNABELL tablets ULD 4. patients who want to become pregnant 5. estrogen dependent malignant tumor (e.g. breast cancer, endometrial cancer), cervical cancer or suspected to have those diseases 6. thrombophlebitis, pulmonary embolism, cerebrovascular accident and coronary artery disease, or past history of those diseases 7. more than 35 years old and smoke more than 15 cigarettes 8. migraine with aura (e.g. fortification spectrum etc.) 9. valvular disease with pulmonary; hypertension or atrial fibrillation valvular disease with past history of subacute infectious endocarditis 10. diabetes with vascular disease (diabetic nephropathy, diabetic retinopathy etc.) 11. primary cause of thrombosis 12. antiphospholipid antibody syndrome 13. within 4 weeks before surgery, within 2 weeks after surgery, within 4 weeks after delivery, or long-term bed rest 14. severe liver damage 15. liver tumor 16. lipid metabolism abnormality 17. hypertension (except mild hypertension) 18. otoscleosis 19. past history of jaundice, persistent pruritus or herpes during pregnancy 20. probably in the middle of bone growth 21. patients who are judged ineligible by doctor in charge for other reasons

Related Information


Public contact
Name Mayuko Miyamoto
Address 2-15 Yamadaoka Suita city Osaka, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3351
Affiliation Osaka University Hospital
Scientific contact
Name Tadashi Kimura
Address 2-15 Yamadaoka Suita city Osaka, Japan Osaka Japan 565-0871
Telephone +81-6-6879-3351
Affiliation Osaka University Hospital