UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026073 |
|---|---|
| Receipt number | 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 17:04:11 |
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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
| Obstetrics 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
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
syoshida1208@gmail.com
Sponsor or person
Institute
Department of Obstetrics and Gynecology
Nara Medical University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029900
