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

Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma

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 Overview

• Status: Withdrawn
• Conditions: Endometriosis; Ovarian Reserve
• Intervention / Treatment: Drug: Dienogest; Drug: Placebo drug; Procedure: Surgery

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi Do
    • Seongnam Si, Gyeonggi Do, Korea, Republic of, 463707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level	3 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the mean change of serum AMH level		1 month after surgery
Compare the trend of mean change of serum AMH level		1 and 3 month after surgery
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
compare the surgical time (minute)	surgical time (minute)	intraoperative
Brief Pain Inventory (BPI) scores		baseline, 1 month after surgery and 3 month after surgery
number of participants with treatment-related adverse events as assessed by CTCAE v4.0		All adverse events from randomization to postoperative 3 months
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 19, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 28, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Dienogest
• Other Study ID Numbers: SNUBH_GO_052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No