UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006469 |
|---|---|
| Receipt number | 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 17:12:49 |
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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
| Obstetrics 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
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
kumakiri@juntendo.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007676
