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

Abstract

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

Estetrol‐Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia

“…E4/DRSP provides contraceptive efficacy based on PI (0.47 pregnancies/100 woman‐years; 95% CI 0.15–1.11), which is similar to marketed DRSP‐containing COCs, such as Yaz ® (PI = 0.80 pregnancies/100 woman‐years; upper limit 95% CI 1.30) and Yasmin ® (PI = 0.57 pregnancies/100 woman‐years; upper limit 95% CI 0.90). Moreover, E4/DRSP has a lower PI compared with recent studies performed in Europe with a DRSP‐only 4 mg 24/4 contraceptive (Slynd ® , Slinda ® , pooled PI = 0.73 pregnancies/100 woman‐years; 95% CI 0.31–1.43) 27 . E4/DRSP bleeding pattern is comparable to EE‐containing COCs and better than a DRSP‐only 4 mg 24/4 contraceptive 27 .…”

“…Moreover, E4/DRSP has a lower PI compared with recent studies performed in Europe with a DRSP‐only 4 mg 24/4 contraceptive (Slynd ® , Slinda ® , pooled PI = 0.73 pregnancies/100 woman‐years; 95% CI 0.31–1.43). 27 E4/DRSP bleeding pattern is comparable to EE‐containing COCs and better than a DRSP‐only 4 mg 24/4 contraceptive. 27 The adverse event profile was consistent with the use of other COCs, with the most common adverse events being menstrual irregularities, acne and headache.…”

“… 27 E4/DRSP bleeding pattern is comparable to EE‐containing COCs and better than a DRSP‐only 4 mg 24/4 contraceptive. 27 The adverse event profile was consistent with the use of other COCs, with the most common adverse events being menstrual irregularities, acne and headache. 28 , 29 , 30 The annual VTE incidence observed in this study (6/10 000 women) is reassuringly low in comparison with annual VTE risks reported in non‐COC users of 0.7–5.8/10 000 women (varying by age), reported by Lidegaard et al., 31 and 5–10/10 000 women reported by Heinemann and Dinger.…”

Metabolic and laboratory effects of a progestin-only pill containing drospirenone 4 mg in comparison to desogestrel 75 µg: a double-blind, double-dummy, prospective, randomised study

“…Both effects were considered clinically not relevant. There is an ongoing debate about the effect of hormonal contraceptives on bone health, and up to date, no closing statement available [51,52]. For 4 mg DRSP, it was demonstrated that the serum oestrogen levels of adult users are in the range of the levels measured during the follicular phase of the normal menstrual cycle.…”

Updates from the Literature, January/February 2021

“…The formulation also offers a longer window for safe dosing. With a half‐life of 30 to 34 hours, it can be taken up to 12 hours late, or 36 hours after the last pill 3 . Norethindrone‐based POPs have a much smaller half‐life, about 10 hours, which results in a roughly 3‐hour window for daily dosing to maintain a steady stream of progestin 4…”