SPADE study

JRCT ID: jRCTs071180042

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Endometriosis
• Date of first enrollment: 14/06/2016
• Target sample size: 200
• Study type: Interventional
• Intervention(s): The laboratory tests are carried out at 4 times before and during treatment period.

Outcome(s)

• Primary Outcome: Change of protein S specific activity (total activity, total antigen level and those ratios)
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kato Kiyoko
• Source(s) of Monetary Support: Mochida Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000022266