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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071180042

Registered date:14/03/2019

SPADE study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEndometriosis
Date of first enrollment14/06/2016
Target sample size200
Countries of recruitment
Study typeInterventional
Intervention(s)The laboratory tests are carried out at 4 times before and during treatment period.

Outcome(s)

Primary OutcomeChange of protein S specific activity (total activity, total antigen level and those ratios)
Secondary OutcomeEffect 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).

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 50age old
GenderFemale
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Katsuko Egashira
Address 3-1-1 Maidashi,Higashi-ku,Fukuoka Fukuoka Japan 812-8582
Telephone +81-92-642-5395
E-mail egasira@gynob.med.kyushu-u.ac.jp
Affiliation Kyushu University Hospital
Scientific contact
Name Kiyoko Kato
Address 3-1-1 Maidashi,Higashi-ku,Fukuoka Fukuoka Japan 812-8582
Telephone +81-92-642-5395
E-mail kkato@med.kyushu-u.ac.jp
Affiliation Kyushu University Hospital