DOROSY: Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02728245
• Collaborator: 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)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 0

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Reserve; Endometriosis	Drug: Dienogest; Drug: Placebo drug; Procedure: Surgery	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Mar 1, 2018
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: Dienogest; Dienogest 2mg po qd; Drug: Placebo drug; Placebo 1 table po qd; Procedure: Surgery; conservative surgery without intent to oophorectomy
Experimental: 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.	Drug: Dienogest; Dienogest 2mg po qd; Procedure: Surgery; conservative surgery without intent to oophorectomy

Outcome Measures

Primary Outcome Measures

1. Compare the mean change of serum Anti-Mullerian Hormone (AMH) level [3 month after surgery]

Secondary Outcome Measures

1. Compare the mean change of serum AMH level [1 month after surgery]

2. Compare the trend of mean change of serum AMH level [1 and 3 month after surgery]

3. Compare the mean change of serum AMH level [baseline and after preoperative dienogest/placebo therapy for 3 months]

4. Compare the revised American fertility society (AFS) score [At surgery]

5. compare the surgical time (minute) [intraoperative]

   surgical time (minute)

6. Brief Pain Inventory (BPI) scores [baseline, 1 month after surgery and 3 month after surgery]

7. number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [All adverse events from randomization to postoperative 3 months]

8. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam Si	Gyeonggi Do	Korea, Republic of	463707

Sponsors and Collaborators

• Seoul National University Hospital
• Kyung Hee University Hospital at Gangdong
• Korea University Guro Hospital
• Ajou University School of Medicine
• Ewha Womans University Mokdong Hospital
• Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kidong Kim, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02728245
• Other Study ID Numbers: SNUBH_GO_052
• First Posted: Apr 5, 2016
• Last Update Posted: Oct 31, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis; Dienogest

Study Results

No Results Posted as of Oct 31, 2017