NCT02728245

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

March 19, 2016

Last Update Submit

October 28, 2017

Conditions

Ovarian ReserveEndometriosis

Outcome Measures

Primary Outcomes (1)

  • Compare the mean change of serum Anti-Mullerian Hormone (AMH) level

    3 month after surgery

Secondary Outcomes (8)

  • 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)

    intraoperative

  • +3 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

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: DienogestDrug: Placebo drugProcedure: Surgery

Case group

EXPERIMENTAL

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: DienogestProcedure: Surgery

Interventions

DienogestDRUG

Dienogest 2mg po qd

Case groupControl group
Placebo drugDRUG

Placebo 1 table po qd

Control group
SurgeryPROCEDURE

conservative surgery without intent to oophorectomy

Case groupControl group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • ≤ Age ≤ 45 and premenopause
  • Plan to undergo conservative surgery for endometriomas

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

Location

MeSH Terms

Conditions

Endometriosis

Interventions

dienogestSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2016

First Posted

April 5, 2016

Study Start

October 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)