ENDOMETRIOSIS study

Phase 4

• Conditions: Endometriosis (ovarian endometrioma); Endometriosis

• Registration Number: JPRN-jRCT1051190028
• Lead Sponsor: Kimura Tadashi

Brief Summary

In this study, patients who had undergone endometriosis surgery were treated with Dienogest and Lunabell tablets ULD for prevention of recurrence, and their preventive efficacy and safety were compared. 35 patients were randomly assigned, and data were collected from 18 patients in the Dienogest group and 17 patients in the Lunabell tablets ULD group, which were statistically analyzed. The cumulative 2-year postoperative recurrence rate was 6% in the Dienogest group and 12% in the Lunabell tablets ULD group

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Study Completion: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 35

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The recurrence rate 2 years of ovarian endometrioma after surgery

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.