Bleeding profile of women using a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg

Palacios, Santiago; Colli, Enrico; Regidor, Pedro‐Antonio

doi:10.1371/journal.pone.0231856

Cited by 27 publications

(21 citation statements)

References 20 publications

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“…Bleeding pattern: control of bleeding profile with 4 mg DRSP in comparison to 75 µg desogestrel. A phase III clinical trial over 9 administration cycles compared bleeding profiles of women treated with 4 mg DRSP and women treated with 75 µg desogestrel [46,47]. The percentage of women with bleeding and spotting decreased in the 4 mg DRSP group from 69.2 % in administration cycle 2 to 56.3 % in administration cycle 9, and in the 75 µg desogestrel group from 74.05 % to 45.3 %.…”

Section: Tolerancementioning

confidence: 99%

“…In addition, during administration cycles 5 – 9, the proportion of women with prolonged bleeding (> 10 days) was significantly lower in the 4 mg DRSP group than in the 75 µg desogestrel group (p < 0.001). Premature study withdrawal due to abnormal uterine bleeding (AUB) occurred in 3.3% of DRSP and 6.6% of 75 µg desogestrel users (p < 0.001) 46 , 47 . In summary, the results of the clinical trials revealed that 4 mg DRSP controlled bleeding patterns better than did 75 µg desogestrel.…”

Section: Safetymentioning

confidence: 99%

See 1 more Smart Citation

Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone

Römer

Bitzer

Egarter

et al. 2021

Geburtshilfe Frauenheilkd

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Hormonal contraceptives are an effective and safe method for preventing pregnancy. Progestins used in contraception are either components of combined hormonal contraceptives (tablets, patches or vaginal rings) or are used as a single active ingredient in progestin mono-preparations (the progestin-only pill (POP), implants, intrauterine systems or depot preparations). Progestins are highly effective in long-term contraception when used properly, and have a very good safety profile with very few contraindications. A new oestrogen-free ovulation inhibitor (POP) has recently been authorised in the USA and the EU. This progestin mono-preparation contains 4 mg of drospirenone (DRSP), which has anti-gonadotropic, anti-mineralocorticoidic and anti-androgenic properties. The hormone administration regimen of 24 days followed by a 4-day hormone-free period was chosen to improve bleeding control and to maintain oestradiol concentrations at early follicular-phase levels, preventing oestrogen deficiency. Clinical trials have demonstrated a high contraceptive effectiveness, a very low risk of cardiovascular side effects and a favourable menstrual bleeding pattern. Due to the long half-life of DRSP (30 – 34 hours), the effectiveness of the preparation is maintained even if a woman forgets to take a pill on a single occasion. Studies involving deliberate 24-hour delays in taking a pill have demonstrated that ovulation inhibition is maintained if a single pill is missed. Following a summary of the current status of oestrogen-free contraception, this review article will describe the clinical development programme of the 4 mg DRSP mono-preparation and the resulting data on the effectiveness and safety of this new oestrogen-free oral hormonal contraceptive.

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Section: Tolerancementioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone

Römer

Bitzer

Egarter

et al. 2021

Geburtshilfe Frauenheilkd

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show abstract

“…Unscheduled bleeding days between the cycle 2–6 were lower in the DRSP group compared to the DSG; excluding the amenorrhoeic women (p = 0.0001, chi-square test). The mean [SD] number of bleeding days was 8.6 [8.52] days vs. 12.9 [16.47] days, p = 0.0233 [ 9 ].…”

Section: Resultsmentioning

confidence: 99%

“…In one study a comparison between DRSP and desogestrel (DSG) was performed showing that in each cycle, up to cycle 7, the proportion of women with unscheduled bleeding including those which did not bleed was statistically significantly lower under the use of DRSP comparing it DSG (p = 0.0001, chi-square test). [16.47] days, p = 0.0233 [9].…”

Section: Bleeding Profilementioning

confidence: 93%

Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime

Palacios

Colli

Regidor³

2020

BMC Women's Health

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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.

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“…Excluding amenorrhoeic women following results were obtained: In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically signi cantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of bleeding days was 8.6 [8.52] days vs. 12.9 [16.47] days, p = 0.0233 [9].…”

Section: Bleeding Pro Lementioning

confidence: 99%

Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. Cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

Palacios

Colli²,

Regidor³

2020

Preprint

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Background: A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone 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.Methods: The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a method with high efficacy and showing a profile with low cardiovascular risks.Study design: Three European and American multicenter clinical trials have been conducted in more than 2.500 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 and7or 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.EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. Clincaltrials.gov: NCT02269241

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Bleeding profile of women using a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg

Cited by 27 publications

References 20 publications

Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone

Oral Progestins in Hormonal Contraception: Importance and Future Perspectives of a New Progestin Only-Pill Containing 4 mg Drospirenone

Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime

Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. Cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

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