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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014770
Receipt No. R000017167
Scientific Title The expression of the sex steroids receptor and serum sex steroids status in uterine fibroids, endometriosis, and uterine adnomyosis
Date of disclosure of the study information 2014/08/06
Last modified on 2014/08/05

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Basic information
Public title The expression of the sex steroids receptor and serum sex steroids status in uterine fibroids, endometriosis, and uterine adnomyosis
Acronym The sex steroids receptor expression in fibroids, endometriosis, and adnomyosis.
Scientific Title The expression of the sex steroids receptor and serum sex steroids status in uterine fibroids, endometriosis, and uterine adnomyosis
Scientific Title:Acronym The sex steroids receptor expression in fibroids, endometriosis, and adnomyosis.
Region
Japan

Condition
Condition uterine fibroma, endometriosis, uterine adenomyosis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate of the role of the expression of sex steroids receptors and serum steroids levels between fibroma, endometriosis, and adenomyosis.
Basic objectives2 Others
Basic objectives -Others retrospectively evaluation of pathogenesis
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the quantification of expression levels of sex steroids receptors in legions obtained from specimens, and comparison of serum levels of sex steroids between diseases.
Key secondary outcomes

Base
Study type

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 no prior treatments
Interventions/Control_2 progestin therapy
Interventions/Control_3 GnRHa therapy
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
40 years-old >=
Gender Female
Key inclusion criteria the patients with uetrine fibroma,who have received surgical treatments
Key exclusion criteria under 20 years old, over 40, or post menopausal women
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Ohmichi
Organization Osaka Medical College
Division name Obstetrics and Gynecology
Zip code
Address 2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL +81-72-683-1221
Email gyn74@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atushi Hayashi
Organization Osaka Medical College
Division name Obstetrics and Gynecology
Zip code
Address 2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL +81-72-683-1221
Homepage URL
Email gyn74@poh.osaka-med.ac.jp

Sponsor
Institute Dept of Obstetrics and Gynececology, Osaka medical college.
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 06 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
2011 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 18 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 05 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 05 Day
Last modified on
2014 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017167

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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