DRKS00028438
Not yet recruiting
Not Applicable
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 sites100 target enrollmentMarch 2, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Exeltis Poland Sp.zo.o.
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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\.
Outcomes
Primary Outcomes
Not specified
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