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Placebo cannot be prepared
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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
| Korea University Guro Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
| Ewha Womans University Mokdong Hospital |
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Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Placebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients. Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. |
|
| Case group | Experimental | Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients. Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest | Drug | Dienogest 2mg po qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the mean change of serum Anti-Mullerian Hormone (AMH) level | 3 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the mean change of serum AMH level | 1 month after surgery | |
| Compare the trend of mean change of serum AMH level | 1 and 3 month after surgery | |
| Compare the mean change of serum AMH level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463707 | South Korea |
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| OTHER |
| Asan Medical Center | OTHER |
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| Placebo drug |
| Drug |
Placebo 1 table po qd |
|
| Surgery | Procedure | conservative surgery without intent to oophorectomy |
|
| baseline and after preoperative dienogest/placebo therapy for 3 months |
| Compare the revised American fertility society (AFS) score | At surgery |
| compare the surgical time (minute) | surgical time (minute) | intraoperative |
| Brief Pain Inventory (BPI) scores | baseline, 1 month after surgery and 3 month after surgery |
| number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | All adverse events from randomization to postoperative 3 months |
| Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months | baseline and after preoperative dienogest/placebo therapy for 3 months |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
| D013514 | Surgical Procedures, Operative |
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