ENDOMETRIOSIS study

JRCT ID: jRCT1051190028

Registered date:26/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Endometriosis (ovarian endometrioma)
• Date of first enrollment: 01/03/2017
• Target sample size: 120
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: The recurrence rate 2 years of ovarian endometrioma after surgery
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Female

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Kimura Tadashi
• Secondary ID(s): UMIN000020865