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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006469
Receipt No. R000007676
Scientific Title Comparison of the efficacy of the preoperative use of dienogest and gonadotropin releasing hormone agonist for endometriosis: A randomized controlled trial
Date of disclosure of the study information 2011/11/01
Last modified on 2015/04/06

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Basic information
Public title Comparison of the efficacy of the preoperative use of dienogest and gonadotropin releasing hormone agonist for endometriosis: A randomized controlled trial
Acronym The efficacy of the preoperative use of dienogest for endometriosis
Scientific Title Comparison of the efficacy of the preoperative use of dienogest and gonadotropin releasing hormone agonist for endometriosis: A randomized controlled trial
Scientific Title:Acronym The efficacy of the preoperative use of dienogest for endometriosis
Region
Japan

Condition
Condition endometriosis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of preoperaive use of dienogest are investigated by comparing surgical outcomes including blood loss, duration of operation and incidence of complication between patients who were administrated dienogest and patients with preoperative GnRH agonist.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes surgical outcomes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dienogest
Interventions/Control_2 GnRH agonist
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

Not applicable
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Cases with uni- or bilateral ovarian endometrioma
Key exclusion criteria Case suspected malignant tumor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Kumakiri
Organization Juntendo University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kumakiri@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kumakiri
Organization Juntendo University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kumakiri@juntendo.ac.jp

Sponsor
Institute Obstetrics and Gynecology
Institute
Department

Funding Source
Organization No
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 YES
Study ID_1 788
Org. issuing International ID_1 Juntendo University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 11 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2016 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 04 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007676

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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