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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Palacios, Santiago Colli, Enrico Regidor, Pedro-Antonio |
| Abstract | Background A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone (DRSP) at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a contraceptive method with high efficacy and showing a profile with low cardiovascular risks. Methods Three European and American multicenter clinical trials have been conducted in more than 2500 patients and more than 25,000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41.9%) had a risk factor for VTE, while in the European studies, 261 patients (16.6%) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and/or 85 to 90 mm HG and no influence on ECG parameters were observed. Conclusions The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors. Trial registration EudraCT registration numbers: 2010–021787-15 & 2011–002396-42 . Clincaltrials.gov: NCT02269241 . |
| Related Links | https://bmcwomenshealth.biomedcentral.com/counter/pdf/10.1186/s12905-020-01080-9.pdf |
| Ending Page | 9 |
| Page Count | 9 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14726874 |
| DOI | 10.1186/s12905-020-01080-9 |
| Journal | BMC Women's Health |
| Issue Number | 1 |
| Volume Number | 20 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2020-10-02 |
| Access Restriction | Open |
| Subject Keyword | Gynecology Maternal and Child Health Reproductive Medicine Estrogen free contraception Cardiovascular side effects ECG Progestogen Spirolactone derivative Drospirenone |
| Content Type | Text |
| Resource Type | Article |
| Subject | Obstetrics and Gynecology Reproductive Medicine |
| Journal Impact Factor | 2.4/2023 |
| 5-Year Journal Impact Factor | 2.9/2023 |
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