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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000879
Receipt No. 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

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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
Obsterics 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
Email

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
Email kikuchi@med.juntendo.ac.jp

Sponsor
Institute Dept. of OB/GY Juntendo univ. school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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