Endometriosis
Conditions
Interventions
The laboratory tests are carried out at 4 times before and during treatment period.
Sponsors
Department of Obstetrics and Gynecology, Kyushu University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of protein S specific activity (total activity, total antigen level and those ratios) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactNatsuko Yokota
Kyushu University Hospital Department of Obstetrics and Gynecology
Outcome results
None listed