Observational study to evaluate the acceptability and bleeding profile with Drospirenone 4 mg, in a regimen of use 24/4 in contraception (Slinda®) including patient who have been taken Slinda® for at least 5 cycles of use during breastfeeding. BreastSlinda® Study. - BREASTSLI-01-21

Exeltis Poland Sp.zo.o.0 个研究点目标入组 100 人开始时间: 2022年3月2日最近更新: 2024年8月19日

试验速览

暂无简介。

•1. Premenopausal women over 18 years of age
•2. Women who used Slinda® for the authorized indication (contraception) and have
•started treatment 5 cycles prior to the visit.
•3. Women starting Slinda® from 4 weeks after delivery
•4. Only Women who were breastfeeding.
•5. Only Women who were taking continuously Slinda from week 4-12 weeks (after delivery) but not longer that 8 months after delivery.
•5. Women must give their informed consent to participate in the study.

•1. Patients with contraindications stated in the summary of characteristics
•2. Patients with severe, acute, or chronic disease (e.g., pancreatitis, liver disease,
•genital tumors, severe renal insufficiency or acute renal failure, history of
•hyperkalaemia, etc.) that clinically could interfere with the evaluation.
•3. Gynecological pathologies such as endometriosis, myomatous uterus, or
•polycystic ovary syndrome.
•4. Coagulopathies or hematologic diseases.
•5. Thromboembolic history.
•6. Consumption of products such as medicinal plants that can induce microsomal
•enzymes, especially cytochrome P450.
•7. Patients who were participating in a clinical trial at the time of entering the study.
•8. Advanced hypertension or diabetes
•9. Known hypersensitivity to components of Slinda®
•10. Undiagnosed abnormal vaginal bleeding
•11. Used of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
•during and two weeks before start of the study
•12. Pregnancy
•13. Women who were breatfeeding and were taking Slinda from 9 months after delivery.

发起方

Exeltis Poland Sp.zo.o.