Z30
Conditions
Interventions
Group 1: Observational study with 1 arm in which the acceptability of Slinda® especially in women who breastfed from 2 to 8 months post-partum in whom the first drug dose will start between 4-12 week
Sponsors
Exeltis Poland Sp.zo.o.
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of Slinda® especially in women who breastfed from 2 to 8 months post-partum in whom the first drug dose will start between 4-12 weeks post-partum where the total duration of treatment was 5 cycles (from 2 to 8 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Acceptability of bleeding pattern assessment b) Tolerability and safety assessment. c) Infant outcome | — |
Countries
Poland
Contacts
Public ContactTomasz Slaski
Exeltis Poland Sp.zo.o.
Outcome results
None listed