A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen

Kimble, Thomas; Burke, Anne E.; Barnhart, Kurt T.; Archer, David F.; Colli, Enrico; Westhoff, Carolyn

doi:10.1016/j.conx.2020.100020

Cited by 42 publications

(68 citation statements)

References 25 publications

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“…Cigarette use in women >35 years old was the most common risk factor in the European studies(10.1% and 12%, respectively) [18,19]. In the US study [20], the incidence of this risk factor was 5.1%. BMI >30 kg/m 2 was the most common risk factor in the US study, representing 35% of participants [20].…”

Section: Obese Womenmentioning

confidence: 90%

“…The results of both studies reveal that the contraceptive effectiveness of 4 mg drospirenone is similar to that of currently available COCs ( Table 2). In the US study among 915 non-breastfeeding women aged 35 years the Pearl Index was 2.9 (95% CI 1.5, 5.1) [20]. A possible bias for the primary endpoint and the safety aspect including adverse events for all data obtained from the three clinical trials is the discontinuation rate, which was 27.8% and 19.8%, respectively, in the two European studies [18,19] and 65% in the US study [20].…”

Section: Phase III Studiesmentioning

confidence: 94%

“…The recorded risk factors were family history of thromboembolic illness, evidence of predisposing conditions for a vascular or metabolic disease, current smoker >35 years or non-smoker >40 years, and body mass index (BMI) !30 kg/m 2 . In the USA, at least 367 participants (36.5%) had a risk factor for VTE [20], while in the European studies, 139 (16.2%) and 104 (14.6%) participants, respectively, had a VTE risk factor [18,19].…”

Section: Safetymentioning

confidence: 98%

“…Efficacy The contraceptive efficacy of 4 mg drospirenone is supported by clinical phase III trials, which included two pivotal European studies [18,19] and one US study [20]. A pooled analysis of the two European studies showed an overall Pearl Index of 0.73 (95% confidence interval [CI] 0.3133, 1.4301) (14,329 cycles of 4 mg drospirenone) and an adjusted Pearl Index of 0.79 (95% CI 0.3410, 1.5562) [19].…”

Section: Phase III Studiesmentioning

confidence: 99%

“…There were also no reports of arterial thromboembolism, myocardial infarction, stroke or pulmonary embolism (Table 3). It is important to point out that the phase III clinical trials included a significant number of participants with risk factors for VTE [18][19][20]. The recorded risk factors were family history of thromboembolic illness, evidence of predisposing conditions for a vascular or metabolic disease, current smoker >35 years or non-smoker >40 years, and body mass index (BMI) !30 kg/m 2 .…”

Section: Safetymentioning

confidence: 99%

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Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Palacios

Regidor²,

Colli

et al. 2020

The European Journal of Contraception & Reproductive Health

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Purpose: The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1-3 months), subdermal implants (every 3-5 years) and intrauterine systems (every 3-5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications. Material and Methods: A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties. Results: The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30-34 h. Conclusions: Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake. ARTICLE HISTORY

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Section: Obese Womenmentioning

confidence: 90%

Section: Phase III Studiesmentioning

confidence: 94%

Section: Safetymentioning

confidence: 98%

Section: Phase III Studiesmentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

See 3 more Smart Citations

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Palacios

Regidor²,

Colli

et al. 2020

The European Journal of Contraception & Reproductive Health

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Obesity, Body Composition, and Sex Hormones: Implications for Cardiovascular Risk

Singh

Covassin

Marlatt

et al. 2021

Comprehensive Physiology

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Cardiovascular disease (CVD) continues to be the leading cause of death in adults, highlighting the need to develop novel strategies to mitigate cardiovascular risk. The advancing obesity epidemic is now threatening the gains in CVD risk reduction brought about by contemporary pharmaceutical and surgical interventions. There are sex differences in the development and outcomes of CVD; premenopausal women have significantly lower CVD risk than men of the same age, but women lose this advantage as they transition to menopause, an observation suggesting potential role of sex hormones in determining CVD risk. Clear differences in obesity and regional fat distribution among men and women also exist. While men have relatively high fat in the abdominal area, women tend to distribute a larger proportion of their fat in the lower body. Considering that regional body fat distribution is an important CVD risk factor, differences in how men and women store their body fat may partly contribute to sex-based alterations in CVD risk as well. This article presents findings related to the role of obesity and sex hormones in determining CVD risk. Evidence for the role of sex hormones in determining body composition in men and women is also presented. Lastly, the clinical potential for using sex hormones to alter body composition and reduce CVD risk is outlined.

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Premenstrual syndrome and premenstrual dysphoric disorder

Nuriyeva

Bachmann²

2022

Gynäkologie

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A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen

Cited by 42 publications

References 25 publications

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature

Obesity, Body Composition, and Sex Hormones: Implications for Cardiovascular Risk

Premenstrual syndrome and premenstrual dysphoric disorder

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