UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018569 |
|---|---|
| Receipt number | R000021492 |
| Scientific Title | The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/02/12 13:22:16 |
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Basic information
Public title
The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas
Acronym
The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas.
Scientific Title
The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas
Scientific Title:Acronym
The evaluation for usefulness of dienogest to prevent decline of ovarian reserve by cystectomy for endometriomas.
Region
| Japan |
Condition
Condition
endometrioma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of administration of dienogest before and after laparoscopic surgery for endometriomas on the ovarian reserve
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum concentrations of AMH, 2 and 1 months before operation, 1,2,6,12 months after operation
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 2mg/day, 8 weeks before operation and 8 weeks after operation
Interventions/Control_2
buserelin acetate 1.8mg/every 4 weeks, twice before operation and twice after operation
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
unilateral or bilateral endometrioma(s) with 4-cm diameter at least
Key exclusion criteria
Hisory of ovarian surgery, History of hormonal therapy within 6 months before surgery, Complication with other endocrinological diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoko Osuka |
Organization
Nagoya University Hospital
Division name
Maternal and Perinatal Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2261
satokoosuka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Osuka |
Organization
Nagoya University Hospital
Division name
Maternal and Perinatal Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442261
Homepage URL
satokoosuka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | 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 | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021492
