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

Phase 2

Withdrawn

• Conditions: Endometriosis; Ovarian Reserve
• Interventions: Drug: Dienogest; Drug: Placebo drug; Procedure: Surgery

• Registration Number: NCT02728245
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Status Verified: 2017-10
• Study Start: 2017-10
• Last Update Submitted: 2017-10-28
• Last Update Posted: 2017-10-31
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Surgery	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	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.
Control group	Placebo drug	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.
Control group	Dienogest	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	Dienogest	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.

Primary Outcome Measures

Name	Time	Method
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level	3 month after surgery

Secondary Outcome Measures

Name	Time	Method
Compare the trend of mean change of serum AMH level	1 and 3 month after surgery
compare the surgical time (minute)	intraoperative	surgical time (minute)
number of participants with treatment-related adverse events as assessed by CTCAE v4.0	All adverse events from randomization to postoperative 3 months
Compare the mean change of serum AMH level	baseline and after preoperative dienogest/placebo therapy for 3 months
Compare the revised American fertility society (AFS) score	At surgery
Brief Pain Inventory (BPI) scores	baseline, 1 month after surgery and 3 month after surgery
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam Si, Gyeonggi Do, Korea, Republic of