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
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
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
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
