Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
NCT ID: NCT02728245
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2017-10-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control group
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.
Surgery
conservative surgery without intent to oophorectomy
Dienogest
Dienogest 2mg po qd
Placebo drug
Placebo 1 table po qd
Case group
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.
Surgery
conservative surgery without intent to oophorectomy
Dienogest
Dienogest 2mg po qd
Interventions
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Surgery
conservative surgery without intent to oophorectomy
Dienogest
Dienogest 2mg po qd
Placebo drug
Placebo 1 table po qd
Eligibility Criteria
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Inclusion Criteria
* In Patients with previous unilateral salpingo-oophorectomy (USO)
* Unilateral ovarian endometrioma with any size is eligible
* 20 ≤ Age ≤ 45 and premenopause
* Plan to undergo conservative surgery for endometriomas
Exclusion Criteria
* Women with current venous thromboembolism or history of such diseases
* Women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases
* Women with current diabetes with vascular lesions or history of such diseases
* Women with current severe liver diseases or history of severe liver diseases with abnormal liver function
* Women with current liver tumor or history of liver tumor
* Women with current or history of sex-hormone dependent malignant tumor or women who were suspected to have a sex-hormone dependent malignant tumor
* Women with vaginal bleeding of unknown causes
* Women with a history of allergic reaction to elements of DNG
* Women with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Women whose non-compliance is expected
* Lactation (treatment with DNG is not recommended in lactating women due to possible excretion in breast milk)
* Any medication that could result in an excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results
20 Years
45 Years
FEMALE
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Korea University Guro Hospital
OTHER
Ajou University School of Medicine
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Asan Medical Center
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Kidong Kim
Associate Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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SNUBH_GO_052
Identifier Type: -
Identifier Source: org_study_id