UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000879 |
|---|---|
| Receipt number | R000000598 |
| Scientific Title | Randomized controlled trial of efficacy and safety of pre-operative GnRH agonist administration for laparoscopic myomectomy. |
| Date of disclosure of the study information | 2008/01/01 |
| Last modified on | 2009/03/06 18:15:58 |
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Basic information
Public title
Randomized controlled trial of efficacy and safety of pre-operative GnRH agonist administration for laparoscopic myomectomy.
Acronym
Effect of GnRHa for LM
Scientific Title
Randomized controlled trial of efficacy and safety of pre-operative GnRH agonist administration for laparoscopic myomectomy.
Scientific Title:Acronym
Effect of GnRHa for LM
Region
| Japan |
Condition
Condition
uterine fibroid
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of pre-operative GnRHa therapy for laparoscopic myomectomy are evaluated by RCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of myomas at 6 months after GnRHa administration.
The side effects during GnRHa administration.
The estimated bleeding during operation, duration of operation and the weight of extracted specimens.
Key secondary outcomes
The recurrence rate evaluated by MRI after LM.
Pregnancy outcome after LM.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
leuprorelin acetate 1.88mg/month
Interventions/Control_2
no administration of GnRHa
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
maximam diameter of largest fibroid present:>5cm but<=7cm
number of fibroids present that are greater than 5cm:<=3
Key exclusion criteria
Patients with a history of hypersensitivity to ingerdients of the investigational drug or to any synthetic LH-RH agent or LH-RH derivative
Women sho are or potentially may be pregnant
Lactating women
Women with non-diagnosable, abnormal bleedng of unknown origin
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takeuchi ,MD |
Organization
Juntendo univ. school of medicine
Division name
ob. & gy
Zip code
Address
Hongo 2-1-1 Bunkyo-ku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwaho Kikuchi ,MD |
Organization
Juntendo univ. school of medicine
Division name
OB/GY
Zip code
Address
Hongo 2-1-1 Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
kikuchi@med.juntendo.ac.jp
Sponsor or person
Institute
Dept. of OB/GY Juntendo univ. school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2008 | Year | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 05 | Day |
Last modified on
| 2009 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000598
