Clinical trial NCT02728245: Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ovarian Reserve
Endometriosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: Korea University Guro Hospital
name: Ajou University School of Medicine
name: Ewha Womans University Mokdong Hospital
name: Asan Medical Center
First posted: 2016-04-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
timeFrame: 3 month after surgery
Secondary outcomes:
measure: Compare the mean change of serum AMH level
timeFrame: 1 month after surgery
measure: Compare the trend of mean change of serum AMH level
timeFrame: 1 and 3 month after surgery
measure: Compare the mean change of serum AMH level
timeFrame: baseline and after preoperative dienogest/placebo therapy for 3 months
measure: Compare the revised American fertility society (AFS) score
timeFrame: At surgery
measure: compare the surgical time (minute)
timeFrame: intraoperative
measure: Brief Pain Inventory (BPI) scores
timeFrame: baseline, 1 month after surgery and 3 month after surgery
measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: All adverse events from randomization to postoperative 3 months
measure: Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
timeFrame: baseline and after preoperative dienogest/placebo therapy for 3 months
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi Do
Study officials:
References: