Back to resultsTrial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma (DOROSY)
Primary Purpose
Ovarian Reserve, Endometriosis
Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dienogest
Placebo drug
Surgery
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Reserve
Eligibility Criteria
Inclusion Criteria:
- Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
- 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:
- Pregnant women or women who were suspected to be pregnant
- 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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Case group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
Secondary Outcome Measures
Compare the mean change of serum AMH level
Compare the trend of mean change of serum AMH level
Compare the mean change of serum AMH level
Compare the revised American fertility society (AFS) score
compare the surgical time (minute)
surgical time (minute)
Brief Pain Inventory (BPI) scores
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
Full Information
NCT ID
NCT02728245
First Posted
March 19, 2016
Last Updated
October 28, 2017
Sponsor
Seoul National University Hospital
Collaborators
Kyung Hee University Hospital at Gangdong, Korea University Guro Hospital, Ajou University School of Medicine, Ewha Womans University Mokdong Hospital, Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02728245
Brief Title
Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
Acronym
DOROSY
Official Title
Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Placebo cannot be prepared
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Kyung Hee University Hospital at Gangdong, Korea University Guro Hospital, Ajou University School of Medicine, Ewha Womans University Mokdong Hospital, Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Reserve, Endometriosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Case group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dienogest
Intervention Description
Dienogest 2mg po qd
Intervention Type
Drug
Intervention Name(s)
Placebo drug
Intervention Description
Placebo 1 table po qd
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
conservative surgery without intent to oophorectomy
Primary Outcome Measure Information:
Title
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
Time Frame
3 month after surgery
Secondary Outcome Measure Information:
Title
Compare the mean change of serum AMH level
Time Frame
1 month after surgery
Title
Compare the trend of mean change of serum AMH level
Time Frame
1 and 3 month after surgery
Title
Compare the mean change of serum AMH level
Time Frame
baseline and after preoperative dienogest/placebo therapy for 3 months
Title
Compare the revised American fertility society (AFS) score
Time Frame
At surgery
Title
compare the surgical time (minute)
Description
surgical time (minute)
Time Frame
intraoperative
Title
Brief Pain Inventory (BPI) scores
Time Frame
baseline, 1 month after surgery and 3 month after surgery
Title
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
All adverse events from randomization to postoperative 3 months
Title
Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
Time Frame
baseline and after preoperative dienogest/placebo therapy for 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
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:
Pregnant women or women who were suspected to be pregnant
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam Si
State/Province
Gyeonggi Do
ZIP/Postal Code
463707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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