UMIN-CTR Clinical Trial

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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