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.
- Conditions
- Z30Contraceptive management
- Registration Number
- DRKS00028438
- Lead Sponsor
- Exeltis Poland Sp.zo.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). <br>
- Secondary Outcome Measures
Name Time Method a) Acceptability of bleeding pattern assessment<br>b) Tolerability and safety assessment.<br>c) Infant outcome<br>