UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044081 |
|---|---|
| Receipt number | R000050329 |
| Scientific Title | The effects of estrogen on blood coagulation, anticoagulation, and fibrinolysis in gynecologic benign diseases: A prospective study. |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2021/05/10 11:24:07 |
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Basic information
Public title
The effects of estrogen on blood coagulation, anticoagulation, and fibrinolysis in gynecologic benign diseases: A prospective study.
Acronym
The effects of estrogen on blood coagulation, anticoagulation, and fibrinolysis in gynecologic benign diseases: A prospective study.
Scientific Title
The effects of estrogen on blood coagulation, anticoagulation, and fibrinolysis in gynecologic benign diseases: A prospective study.
Scientific Title:Acronym
The effects of estrogen on blood coagulation, anticoagulation, and fibrinolysis in gynecologic benign diseases: A prospective study.
Region
| Japan |
Condition
Condition
gynecologic benign diseases
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of blood coagulation, anticoagulation, and fibrinolysis due to the increased or decreased estradiol level by medication among gynecologic benign diseases and controlled ovarian hyperstimulation by means of Rotational thromboelastometry and Endogenous thrombin potential-based activated protein C sensitivity ratio assay.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes of blood coagulation, anticoagulation, and fibrinolysis due to the increased or decreased estradiol level.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The parameters of Rotational thromboelastometry and Endogenous thrombin potential-based activated protein C sensitivity ratio.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 who are diagnosed as uterine fibroids, adenomyosis, endometriosis, endometrial polyps, or ovarian cysts by gynecological practice with and without Gonadotropin releasing hormone agonist/antagonist.
Patients during non-ovarian stimulation cycles.
Patients during controlled ovarian hyperstimulation cycles.
Key exclusion criteria
Patients medicated with antiplatelets or anticoagulants.
Patients affected by venous thromboembolism.
Patients complicated with diseases involving platelets, coagulation, fibrinolysis, anticoagulation, or antifibrinolysis system.
Patients with anemia (Hb< 8.0 g/dL).
Patients after menopause.
Patients with serious liver disease (or AST <= 100 U/L).
Patients with severe renal disease (or serum creatinine <= 1.3 mg/dL).
Pregnant women.
Women during lactation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Itoh |
Organization
Hamamatsu University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2309
hitou-endo@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Todo |
Organization
Hamamatsu University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2309
Homepage URL
D21022@hama-med.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
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
浜松医科大学附属病院(静岡県)/Hamamatsu University Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of the changes of blood coagulation, anticoagulation, and fibrinolysis due to the increased or decreased estradiol level by medication among gynecologic benign diseases and controlled ovarian hyperstimulation.
Management information
Registered date
| 2021 | Year | 04 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050329
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
