UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014770 |
|---|---|
| Receipt number | 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 23:39:20 |
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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
| Obstetrics 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
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
gyn74@poh.osaka-med.ac.jp
Sponsor or person
Institute
Dept of Obstetrics and Gynececology, Osaka medical college.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017167
