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

• Published in: The European journal of contraception & reproductive health care 2020-06, Vol.25 (3), p.221-227
• Main Authors: Palacios, Santiago, Regidor, Pedro-Antonio, Colli, Enrico, Skouby, Sven Olaf, Apter, Dan, Roemer, Thomas, Egarter, Christian, Nappi, Rossella E., Skřivánek, Aleš, Jakimiuk, Artur J., Weyers, Steven, Ács, Nándor, Elia, David, Gemzell Danielsson, Kristina, Bitzer, Johannes
• Format: Article
• Language: English
• Subjects: Androstenes - pharmacology; Birth control; Clinical Trials as Topic; Contraceptives, Oral - pharmacology; Drospirenone; Female; Humans; oestrogen-free contraception; Ovulation Inhibition - drug effects; progestins; Regulatory approval; spirolactone derivative; Treatment Outcome
• ISSN: 1362-5187; 1473-0782
• DOI: 10.1080/13625187.2020.1743828

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.