UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009143 |
|---|---|
| Receipt number | R000010716 |
| Scientific Title | Efficacy of YAZ on long term maintenance of endometriosis after laparoscopic surgery |
| Date of disclosure of the study information | 2014/12/31 |
| Last modified on | 2015/01/30 19:54:31 |
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Basic information
Public title
Efficacy of YAZ on long term maintenance of endometriosis after laparoscopic surgery
Acronym
YAZ on recurrence of endometriosis after surgery
Scientific Title
Efficacy of YAZ on long term maintenance of endometriosis after laparoscopic surgery
Scientific Title:Acronym
YAZ on recurrence of endometriosis after surgery
Region
| Japan |
Condition
Condition
endometriosis(chocolate cyst)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of YAZ® on long time maintenance of endometriosis in patients after laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Recurrence rate of endometriosis is defined as primary endpoint.
Definition of endometriosis:identification of chocolate cyst over 2cm of diameter
Key secondary outcomes
1)VAS value for menstrual pain, non-menstrual chronic pelvic pain, or dyspareunia
2)Menstrual Distress Questionnaire(MDQ) score
3)Laboratory test values including CA-125, serum hormone, or d-dimer.
4)Concomitant medications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of YAZ after surgery of endometriosis
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Reproductive age of women whose age of 20 to 45
2)Diagnosed as endometriosis with chocolate cyst which should be excised by laparoscopic surgery
3)Diagnosed as dysmenorrhea at visit of 3 month after surgery (Meet to indication of YAZ®)
4)Provide written informed consent
Key exclusion criteria
1)Patient with no symptom during menstruation in 3 months after the surgery
2)Contraindication of YAZ
3)Administrating any of hormonal drugs after surgery except for YAZ
4)Patients for whom participation in this study was judged to be inappropriate by the investigator
Target sample size
133
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University School of Medicine
Division name
Dept. of Obstetrics and Gynecology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, JAPAN
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University School of Medicine
Division name
Dept. of Obstetrics and Gynecology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, JAPAN
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo Tokyo Geriatric Medical Center, Medical Topia Soka Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学医学部付属病院本院、順天堂大学医学部附属順天堂東京江東高齢者医療センター、メディカルトピア草加病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 31 | 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 | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
| 2012 | Year | 10 | Month | 18 | Day |
Last modified on
| 2015 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010716
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
