UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009819
Receipt number R000011508
Scientific Title Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma
Date of disclosure of the study information 2013/01/21
Last modified on 2013/07/20 14:48:51

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Basic information

Public title

Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma

Acronym

Postoperative recurrence prevention by dienogest treatment in ovarian endometrioma

Scientific Title

Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma

Scientific Title:Acronym

Postoperative recurrence prevention by dienogest treatment in ovarian endometrioma

Region

Japan


Condition

Condition

Ovarian endometrioma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to evaluate the effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome is to evaluate the effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma.

Key secondary outcomes

The secondary outcome is to evaluate the effects of long-term dienogest treatment on postoperative recurrence of pain in ovarian endometrioma.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Medicine: Dienogest
Treatment length:1 year postoperation
Dose: 2 mg per day

Interventions/Control_2

Medicine: no treatment

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

45 years-old >

Gender

Female

Key inclusion criteria

A person who underwent a conservative surgery for ovarian endometrioma; cystectomy or ablation of ovarian endometrioma.

Key exclusion criteria

A person who has allergy for dienogest and who wish to bear children right now.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshifumi Takahashi

Organization

Yamagata University, Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

Iida-nishi 2-2-2, Yamagata

TEL

023-628-5393

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshifumi Takahashi

Organization

Yamagata University, Faculty of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

Iida-nishi 2-2-2, Yamagata

TEL

023-628-5393

Homepage URL


Email

totakaha@med.id.yamagata-u.ac.jp


Sponsor or person

Institute

Tohoku Gynecologic Cancer Unit

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

山形大学医学部附属病院(山形県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 20 Day

Last modified on

2013 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011508


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name