UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044081
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email D21022@hama-med.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.