UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016528 |
|---|---|
| Receipt number | R000018619 |
| Scientific Title | Efficacy of Levonorgestrel-Releasing Intrauterine System for Treatment of Atypical Endometrial Hyperplasia |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2020/11/29 22:13:28 |
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Basic information
Public title
Efficacy of Levonorgestrel-Releasing Intrauterine System for Treatment of Atypical Endometrial Hyperplasia
Acronym
LNG-IUS for Treatment of Atypical Endometrial Hyperplasia
Scientific Title
Efficacy of Levonorgestrel-Releasing Intrauterine System for Treatment of Atypical Endometrial Hyperplasia
Scientific Title:Acronym
LNG-IUS for Treatment of Atypical Endometrial Hyperplasia
Region
| Japan |
Condition
Condition
Atypical endometrial hyperplasia, complex
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial is started in Japan to investigate the treatment efficacy and adverse effects of Levonorgestrel-releasing intrauterine system
(LNG-IUS) in endometrial hyperplasia patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre- and post-treatment pathological findings of endometrial hyperplasia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levonorgestrel-releasing intrauterine
device
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Age 20 and over
2. Patients must have signed an approved informed consent.
Key exclusion criteria
1. No active luteal hormone dependent tumor
2. No advanced endometrial cancer
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Kobayashi |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
norinorikingyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Mitamura |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
Homepage URL
takami@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and
Gynecology, Hokkaido University
Graduate School of Medicine
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
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
| 2015 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 13 | Day |
Last modified on
| 2020 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018619
| 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 |
