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

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ClinicalTrials.gov Identifier: NCT02728245
Recruitment Status : Withdrawn (Placebo cannot be prepared)
First Posted : April 5, 2016
Last Update Posted : October 31, 2017
Sponsor:
Collaborators:
Kyung Hee University Hospital at Gangdong
Korea University Guro Hospital
Ajou University School of Medicine
Ewha Womans University Mokdong Hospital
Asan Medical Center
Information provided by (Responsible Party):
Kidong Kim, Seoul National University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Compare the mean change of serum Anti-Mullerian Hormone (AMH) level [ Time Frame: 3 month after surgery ]

Secondary Outcome Measures :
  1. Compare the mean change of serum AMH level [ Time Frame: 1 month after surgery ]
  2. Compare the trend of mean change of serum AMH level [ Time Frame: 1 and 3 month after surgery ]
  3. Compare the mean change of serum AMH level [ Time Frame: baseline and after preoperative dienogest/placebo therapy for 3 months ]
  4. Compare the revised American fertility society (AFS) score [ Time Frame: At surgery ]
  5. compare the surgical time (minute) [ Time Frame: intraoperative ]
    surgical time (minute)

  6. Brief Pain Inventory (BPI) scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and after preoperative dienogest/placebo therapy for 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728245


Locations
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Korea, Republic of
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kidong Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02728245    
Other Study ID Numbers: SNUBH_GO_052
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Dienogest
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents