Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake

Duijkers, Ingrid; Heger-Mahn, Doris; Drouin, Dominique; Colli, Enrico; Skouby, Sven O.

doi:10.1016/j.contraception.2015.12.007

Cited by 48 publications

(51 citation statements)

References 17 publications

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“…Body weight changes. There were no significant changes in average body weight during short-and long-term studies in participants who received 4 mg drospirenone [16][17][18], confirming the data in the literature which have established no association with weight gain or significant changes in percent body fat with drospirenone [26].…”

Section: E 2 Levels and Bonesupporting

confidence: 82%

“…Progestin-only formulation Ovulation inhibition despite delayed intake An open randomised study was designed to evaluate the potential of 4 mg drospirenone to maintain ovulation inhibition in young healthy women (n ¼ 127) despite several 24 h pill intake delays [17]. It was shown that the ovulation rate with 4 mg drospirenone was much lower than that with traditional POPs (30-40%); it was comparable or even slightly lower than the ovulation rate with COCs (1.1-2.0%) and the ovulation rate with 75 lg desogestrel after three programmed delays of 12 h (1.0%) [17].…”

Section: Phase II Studiesmentioning

confidence: 99%

See 1 more Smart Citation

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: E 2 Levels and Bonesupporting

confidence: 82%

Section: Phase II Studiesmentioning

confidence: 99%

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

Self Cite

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show abstract

“…The overall bleeding profile improved considerably. Duijkers el al [ 36 ] could also show that despite the 4-day hormone free period and multiple intentional 24-hours delays in tablet intake, ovulation inhibition was maintained. This property distinguishes this new generation estrogen free pill from traditional POPs by allowing a “safety window” or flexibility in intake of 24 hours; that means doubling the window of intake.…”

Section: New Developments and Future Perspectivesmentioning

confidence: 99%

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

Regidor¹

2018

Oncotarget

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The contraceptive pill is an effective and very safe method to control pregnancies. It was developed 60 years ago, and despite, that the composition has been the same since it was first developed (estrogen and progestogen), along the years the concentration of ethinyl estradiol has been reduced to improve tolerability. Nevertheless, progestogens are the basic active agent of hormonal contraception. The mechanism of progestogens is a multimodal one and basically three modes of contraceptive action can be distinguished:(a) A strong antigonadotrophic action leading to the inhibition of ovulation. The necessary dosage of ovulation inhibition per day is a fixed dosage that is inherent to each progestogen and independent of the dosage of estrogen used or the partial activities of the progestogen or the mode of application. (b) Thickening of the cervical mucus to inhibit sperm penetration and (c) Desynchronization of the endometrial changes necessary for implantation.The on the market available progestogens used for contraception are either used in combined hormonal contraceptives (in tablets, patches, or vaginal rings) or as progestogen only contraceptives. Progestogen only contraceptives are available as daily oral preparations, monthly injections, implants (2-3 years), and Intrauterine Systems (IUS). Even the long acting progestogens are highly effective in typical use and have a very low risk profile, with few contraindications.According to their introduction into the market progestogens, in combined hormonal contraceptives, have been described as first, second, third and fourth generation progestogens. Also, progestogens can be derived from testosterone, progesterone, and spironolactone that determine pharmacodynamic and pharmacokinetic differential effects. These effects contribute to the tolerability and additional beneficial or therapeutic effects whether used in combined oral contraceptives COC or as progestogen only drugs enhancing the individual options for different patient profiles.The new development of polymers for vaginal rings allowed on one side the improvement of the estrogen/progestogen combination in these rings especially regarding the comfort of use for women (avoiding of cold chain use or packages with up to six-month rings e.g.) and on the other side the development of progestogen only formulations. Another future development will be the introduction of new progestogen only pills that will provide effective contraceptive protection with more favourable bleeding patterns and a maintenance of ovulation inhibition after scheduled 24-h delays in pill intake than the existing pop with desogestrel.

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“…In comparison to desogestrel the bleeding pattern with drospirenone showed less bleeding in terms of bleeding/spotting days and episodes, and the contribution of scheduled bleeding days (as opposed to spotting days) to these. Previous studies report comparable differences between ovulation inhibition and hormonal values with drospirenone versus desogestrel [16,17]. The desogestrel group was characterized by a relatively high proportion of the bleeding pattern variables amenorrhea, infrequent bleeding, frequent bleeding, and prolonged bleeding when compared to the group taking drospirenone.…”

Section: Plos Onementioning

confidence: 73%

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

Palacios

Colli

Regidor³

2020

PLoS ONE

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Maintenance of ovulation inhibition with a new progestogen-only pill containing drospirenone after scheduled 24-h delays in pill intake

Cited by 48 publications

References 17 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

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

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

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