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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

NCT02728245 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-10-31

No results posted yet for this study

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

Conditions

  • Ovarian Reserve
  • Endometriosis

Interventions

DRUG

Dienogest

Dienogest 2mg po qd

DRUG

Placebo drug

Placebo 1 table po qd

PROCEDURE

Surgery

conservative surgery without intent to oophorectomy

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • Korea University Guro Hospital

    collaborator OTHER

  • Ajou University School of Medicine

    collaborator OTHER

  • Ewha Womans University Mokdong Hospital

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728245 on ClinicalTrials.gov