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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026073
Receipt No. R000029900
Scientific Title Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma
Date of disclosure of the study information 2017/02/13
Last modified on 2017/02/09

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Basic information
Public title Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma
Acronym Goserelin trial
Scientific Title Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma
Scientific Title:Acronym Goserelin trial
Region
Japan

Condition
Condition Endometriosis, myoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ascess the optimal administration frequency of goserelin acetate for patients with endometriosis complicated uterine myoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Change of diameter of uterine myoma (measured by MRI) before and after administration
Key secondary outcomes Changes of VAS score
Chages of serum FSH, LH and estradil

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 goserelin acetate injection 3 times every 4 weeks
Interventions/Control_2 goserelin acetate injection 6 times every 4 weeks
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
50 years-old >
Gender Female
Key inclusion criteria patients with endometriosis and uterine myoma
premenopausal women
Key exclusion criteria pregnant patient
severe clinical complication (ex.cancer)
patients who were desired for emergent operation
unknown genital bleeding
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Yoshida
Organization Nara Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 840, Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Email syoshida1208@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shozo Yoshida
Organization Nara Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 840, Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Homepage URL
Email syoshida1208@gmail.com

Sponsor
Institute Department of Obstetrics and Gynecology
Nara Medical University
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
2017 Year 02 Month 13 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
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2017 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029900

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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