Unique ID issued by UMIN | UMIN000022266 |
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Receipt number | R000025653 |
Scientific Title | The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis. |
Date of disclosure of the study information | 2016/05/10 |
Last modified on | 2020/05/13 10:20:00 |
The Influence on SPecific Activity of protein S and coagulation system :
Dienogest and low dose estrogen-progestin for Endometriosis.
The Influence on SPecific Activity of protein S and coagulation system :
Dienogest and low dose estrogen-progestin for Endometriosis. (SPADE)
The Influence on SPecific Activity of protein S and coagulation system :
Dienogest and low dose estrogen-progestin for Endometriosis.
The Influence on SPecific Activity of protein S and coagulation system :
Dienogest and low dose estrogen-progestin for Endometriosis. (SPADE)
Japan |
Endometriosis
Obstetrics and Gynecology |
Others
NO
To clarify an influence of dienogest and low dose estrogen-progestin for endometriosis on protein S- specific activity.
Others
Change of protein S-specific activity (total activity, total antigen level and those ratios)
Change of protein S specific activity (total activity, total antigen level and those ratios)
Effect of dienogest and low dose estrogen-progestin on the parameters of coagulation system (excluding protein S specific activity), incidence of venous thromboembolism, incidence ratios of adverse event (including the abnormal change of laboratory test to be clinically problem).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Other |
The laboratory tests are carried out at 4 times before and during treatment period.
20 | years-old | <= |
50 | years-old | > |
Female
1. Patients with treatment start plan of dienogest or low dose estrogen-progestin for endometriosis.
2. Female patients with more than 20 years and less than 50 years at the date of informed consent.
3. Patients with menstrual cycle.
4. Patients providing the written informed consent.
1. Patients with pregnant or the possibility of pregnancy.
2. Patients with post partum within 4 weeks or with lactation.
3. Patients with abnormal genital bleeding not to be diagnosed.
4. Patients with the complication of malignant tumor or the suspicion of complication.
5. Patients with severe hepatic disorder or hepatic tumor.
6. Patients within 4 weeks after the operation (excluding operational duration of less than 30 min).
7. Patients without continuous administration for 24 weeks.
8. Patients with treatment history of steroidal hormones including sex hormones and GnRH agonist within the past 3 months.
9. Patients under anticoagulation and antiplatelet drug.
10. Patients with hypersensitivity to the constituents of the study drug (dienogest tablets or low dose estrogen-progestin tablets).
11. Patients with contraindication of Lunabell tablet LD/ULD and Yaz tablet in low dose estrogen-progestin group.
12. Patient who is judged to be inappropriate for study participation for any reason by the doctor.
200
1st name | |
Middle name | |
Last name | Kiyoko Kato |
Kyushu University Hospital
Department of Obstetrics and Gynecology
3-1-1, Maidashi, Higashi-Ku, Fukuoka
092-642-5395
kkato@med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Natsuko Yokota |
Kyushu University Hospital
Department of Obstetrics and Gynecology
3-1-1, Maidashi, Higashi-Ku, Fukuoka
092-642-5395
natsuko.yokota.192@s.kyushu-u.ac.jp
Department of Obstetrics and Gynecology, Kyushu University Hospital
Clinical Research Support Center Kyushu
Other
JAPAN
NO
九州大学病院(福岡県)、長崎国際大学(長崎県)、国家公務員共済組合連合会 浜の町病院(福岡県)、医療法人 親愛ステーションクリニック(福岡県)、医療法人 中央レディスクリニック(福岡県)、北九州市立医療センター(福岡県)、独立行政法人地域医療機能推進機構JCHO九州病院(福岡県)、済生会支部福岡県 済生会福岡総合病院(福岡県)、日本赤十字社 福岡赤十字病院(福岡県)、医療法人社団 高邦会 福岡山王病院(福岡県)、医療法人社団 水光会 宗像水光会総合病院(福岡県)、国立病院機構福岡東医療センター(福岡県)、順天堂大学医学部附属順天堂医院(東京都)、公益財団法人東京都保険医療公社 東部地域病院(東京都)、越谷市立病院(埼玉県)
2016 | Year | 05 | Month | 10 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 25 | Day |
2016 | Year | 05 | Month | 12 | Day |
2016 | Year | 06 | Month | 01 | Day |
2019 | Year | 06 | Month | 30 | Day |
2019 | Year | 08 | Month | 27 | Day |
2019 | Year | 12 | Month | 23 | Day |
Prospective cohort study
Dienogest group and low dose estrogen-progestin group patients who take hormonal treatment for endometriosis from May X,2016 to September 30,2017 and meet inclusion criteria.
Clinical examination
Protein S-specific activity,Protein S activity,Protein C activity,PT,APTT,D-dimer,fibrinogen,Thrombin-antithrombin complex,estradiol,progesteron
2016 | Year | 05 | Month | 10 | Day |
2020 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025653
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