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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014541
Receipt No. R000016914
Scientific Title Clinical trial on the relationship between oral contraceptives and thromboembolism in the patient with thrombophilia
Date of disclosure of the study information 2014/07/22
Last modified on 2019/06/12

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Basic information
Public title Clinical trial on the relationship between oral contraceptives and thromboembolism in the patient with thrombophilia
Acronym Clinical trial on the relationship between oral contraceptives and thromboembolism in the patient with thrombophilia
Scientific Title Clinical trial on the relationship between oral contraceptives and thromboembolism in the patient with thrombophilia
Scientific Title:Acronym Clinical trial on the relationship between oral contraceptives and thromboembolism in the patient with thrombophilia
Region
Japan

Condition
Condition Thromboembolism
Classification by specialty
Hematology and clinical oncology Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the relationship between the reduction rate of protein S levels after oral contraceptives and thrombophilia.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The reduction rate of protein S levels after oral contraceptives
2. The relationship between protein S levels and thrombophilia
Key secondary outcomes 1. The prevalence of thromboembolism
2. The relationship between thromboembolism and thrombophilia

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
18 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Women who are planning oral contraceptives
Key exclusion criteria 1. Women who took oral contraceptives within three months
2. Women who delivered within three months
3. Women who take anticoagulant and/or antiplatelet agents
4. Emergency contraception
5. Women who are less than 18 years-old
6. Women who do not wish for disclosing the individual results such as hereditary disposition
Target sample size 1350

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Yoshimatsu
Organization National Cerebral and Cardiovascular Center of Japan
Division name Department of Perinatology and Gynecology
Zip code 565-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL +81-6-6833-5012
Email yoshimatsu.jun.hp@ncvc.go.jp

Public contact
Name of contact person
1st name Takekazu
Middle name
Last name Miyoshi
Organization National Cerebral and Cardiovascular Center of Japan
Division name Department of Perinatology and Gynecology
Zip code 565-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL +81-6-6833-5012
Homepage URL
Email gomiyoshi0327@yahoo.co.jp

Sponsor
Institute National Cerebral and Cardiovascular Center of Japan
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center of Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Chayamachi Ladies Clinic
Name of secondary funder(s) Japan Cardiovascular Research Foundation

IRB Contact (For public release)
Organization Institutional Ethics Committee of National Cerebral and Cardiovascular Center
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Tel +81-6-6833-5012
Email plandiv@ml.ncvc.go.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 国立循環器病研究センター(大阪府)/ National Cerebral and Cardiovascular Center of Japan(Osaka, Japan)
茶屋町レディースクリニック(大阪府)/Chayamachi Ladies Clinic (Osaka, Japan)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 22 Day

Related information
URL releasing protocol NA
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30891674
Number of participants that the trial has enrolled 394
Results
Free PS antigen and activity levels and antithrombin activity levels decreased significantly. PC activity levels increased significantly. Larger reductions in free PS antigen and activity levels occurred with COC comprising either 30ug ethinylestradiol/desogestrel or 20ug ethinylestradiol/drospirenone than that comprising 35ug ethinylestradiol/norethisterone. In four women with the Japanese-specific PS K196E mutation, mean PS activity was 65% before COC use and 57% during COC use.
Results date posted
2019 Year 06 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 04 Month 19 Day
Baseline Characteristics
All subjects were healthy Japanese women aged 18-49 years seen at the Chayamachi Ladies Clinic of Japan between July 2014 and November 2016 who were beginning to use low-dose COCs.
Participant flow
After the control menstrual cycle, women selected 1 of 5 categories of low-dose COC commonly available in Japan at their own discretion. Blood samples were taken at enrollment and the third or fourth week after COC use began.
Adverse events
Thrombosis event was observed in three cases (0.8%) during the first cycle of low-dose COC use.
Outcome measures
We investigated the effects of low-dose
COCs and the Japanese-specific PS K196E mutation on anticoagulation factors in Japanese women.
Plasma levels of PS, PC, and AT antigen and activity were measured. In all women, the PS K196E (rs121918474) genotype was determined.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 30 Day
Date of IRB
2014 Year 06 Month 13 Day
Anticipated trial start date
2014 Year 07 Month 22 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
2017 Year 07 Month 14 Day
Date trial data considered complete
2018 Year 01 Month 14 Day
Date analysis concluded
2018 Year 02 Month 17 Day

Other
Other related information Protein S antigen and activity
Protein C antigen and activity
Antithrombin antigen and activity
Protein S K196E mutation

Because the accumulation of the cases was delayed, we extended a case registration period for two years from six months.

Management information
Registered date
2014 Year 07 Month 12 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016914

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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