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

Endometriosis Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02728245
• Other study ID #: SNUBH_GO_052
• Status: Withdrawn
• Phase: Phase 2
• First received: March 19, 2016
• Last updated: October 28, 2017
• Start date: October 2017
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Reserve

Intervention

Drug:
• Dienogest
Dienogest 2mg po qd
• Placebo drug
Placebo 1 table po qd

Procedure:
• Surgery
conservative surgery without intent to oophorectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam Si	Gyeonggi Do

Sponsors (6)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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