UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003098
Receipt number R000003735
Scientific Title Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/26 22:06:36

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Basic information

Public title

Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery

Acronym

Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis

Scientific Title

Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery

Scientific Title:Acronym

Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis

Region

Japan


Condition

Condition

the recurrence of endometriosis after laparoscopic surgery

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1.During the observation period, the degree of pain will be evaluated by visual analogue scale (VAS) using medical examination by interview
2.During the observation period, the pattern of genital bleeding will be evaluated using medical examination by interview
3.The degree of pain and the degree of genital bleeding during the rest period
will be evaluated using medical examination by interview

Key secondary outcomes

In patients with recurrent ovarian chocolate cyst, change in diameter of the ovarian chocolate cyst during the observation period will be evaluated.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One cycle regimen (7 weeks) consists of a consecutive administration of 1 mg of dienogest twice a day for 6 weeks followed by the rest for a week. The cycled regimen will be continued for a year.

Interventions/Control_2

One cycle regimen (7 weeks) consists of a consecutive administration of low dose oral contraceptive for 6 weeks followed by the rest for a week. The cycled regimen will be continued for a year.

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

15 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

Fifty patients with recurrent endometriosis after laparoscopic surgery who met the following inclusion criteria in our facility were enrolled. Written informed consent was obtained from all patients.
1) Patients with histologically proven endometriosis at the first surgical examination
2) Patients without histologically proven adenomyosis at the first surgical examination
3) Patients with recurrent endometriosis related pain, such as dysmenorrhea,
dyspareunia, dyschezia, and the degree of the recurrent pain is the same as that of before surgery.

Key exclusion criteria

1) Patients with undiagnosed genital bleeding
2) Pregnant women or possibly pregnant women

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwaho Kikuchi

Organization

Juntendo University faculty of medicine

Division name

department of OB/GY

Zip code


Address

Hongo 2-1-1 Bunkyo-ku

TEL

03-3813-3111

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University faculty of medicine

Division name

department of OB/GY

Zip code


Address


TEL


Homepage URL


Email

kikuchiban@hotmail.com


Sponsor or person

Institute

Juntendo University faculty of medicine
department of OB/GY

Institute

Department

Personal name



Funding Source

Organization

Juntendo University faculty of medicine
department of OB/GY

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 01 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

Preinitiation

Date of protocol fixation

2009 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 01 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

2010 Year 01 Month 26 Day

Last modified on

2010 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003735


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name