UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014541 |
|---|---|
| Receipt number | 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 11:17:32 |
* 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
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 | Obstetrics 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
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
gomiyoshi0327@yahoo.co.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center of Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
