Three new hormonal contraceptive products were launched in 2009. Dr Meg Thomas, a GP with an interest in sexual health, outlines their pros and cons.
This review will focus on three contraceptive products launched in 2009 – Qlaira, NuvaRing and Ellaone. In terms of their significance, it is likely that emergency contraceptive product Ellaone will have the biggest impact on practice.
This is the first combined oral contraceptive (COC) to combine estradiol valerate – a naturally occurring oestrogen – and the synthetic progestogen dienogest. The latter has not been marketed in the UK before, but has been available in Germany for a decade.
The failure rate for Qlaira is 0.34 failures per 100 woman-years in women aged 18-50, and 0.4 in women aged 18-35. This appears to be similar to that of other COCs containing ethinylestradiol.1
There are no figures on long-term safety for Qlaira, and until further data emerge it must be assumed to have the same risks and benefits of other COCs.
Qlaira involves a complex quadriphasic regimen and the missed-pill advice is also more complicated than with other COCs. As the ‘actual’ (real-life) failure rate for the COC generally is about eight pregnancies per 100 woman-years,2 it is arguable that promoting simple, effective, long-acting methods should be a priority, rather than complex oral regimes.
The oestrogen in Qlaira occurs naturally, and a recent study found significantly fewer bleeding and spotting days compared with a COC containing ethinylestradiol.3 But my view is that there is not convincing evidence of overall benefit on cycle control.
Similarly, some HRT products contain natural oestrogens, and these do not have a more favourable safety profile.4,5
Qlaira may be theoretically less likely to cause side-effects such as mood change and headaches that may occur during oestrogen withdrawal in the pill-free week of 21/7 COCs. However, a recent review concluded the evidence for any actual advantages of Qlaira over other COCs is limited. It is also claimed that dienogest demonstrates no androgenic effects, but side-effects and tolerability are comparable to other COCs.1
At £8.39 per cycle, Qlaira is significantly more expensive than commonly used Pills.
This combined vaginal ring releases 15µg per day of ethinylestradiol and 120µg per day of etonogestrel. It is latex-free, flexible, and transparent.
Contraindications are as for COCs. Anatomical problems such as prolapse may also be a contraindication. Hepatic enzyme-inducing drugs may reduce efficacy.
One ring is inserted for three weeks then removed. After seven days, during which a bleed usually occurs, a new ring is inserted.
This appears to be similar to that of COCs.6
The incidence of serious adverse events to date is very low but there is currently insufficient epidemiological evidence to compare the safety of NuvaRing with COCs.
Systemic exposure to ethinylestradiol is 50% lower than that of the COC and this carries a theoretical benefit. Acceptability is similar to that for the COC.7
Vaginal administration avoids first-pass metabolism and gastrointestinal interference with absorption.
The main advantage of NuvaRing is improved cycle control, in comparison with the COC.6 Women who have persistent problems with breakthrough bleeding and do not object to the concept of a vaginal method may well prefer it as an option. At £9 per cycle it is a comparatively expensive hormonal method.
Ulipristal acetate is a second-generation selective progesterone receptor modulator (SPRM). SPRMs are steroid-derived compounds with mild or potent antiprogestogenic activity. They exert contraceptive activity by various mechanisms including blockade of ovulation and endometrial desynchronisation.
It was launched in October 2009 as Ellaone, a single tablet containing 30mg of micronised ulipristal acetate. It is licensed for emergency contraception up to 120 hours after unprotected sexual intercourse.
Efficacy may be reduced by hepatic enzyme inducers or drugs that increase gastric pH.
Allergy and pregnancy are the only absolute contraindications. It is not recommended for asthmatics dependent on oral steroids.
It is the first emergency contraception to have evidence of efficacy five days after unprotected intercourse and to be licensed for this use.8,9
Although long-term data are awaited, the risk-benefit ratio is considered favourable.10,11
Ellaone is the first oral (non-invasive) emergency contraceptive with good and sustained efficacy beyond 72 hours. It is well tolerated. No adverse outcomes have been reported in the small number of unintended pregnancies that have occurred to date.
Although at £16.95 per dose it is more expensive than levonorgestrel emergency contraception, cost-effectiveness has been suggested by one study.10
A recent meta-analysis of studies comparing ulipristal with levonogestrel taken 0-72 hours after unprotected intercourse found 1.4% of women became pregnant in the ulipristal group compared with 2.2% in the levonorgestrel group.9
But ulipristal acetate has potential beyond being an emergency contraception. It is closely related to mifepristone – a first-generation SPRM – which the World Health Organization has recommended as a first-line emergency contraception.12
Mifepristone is also an effective licensed agent for medical termination in the first two months of pregnancy.
The broader application of SPRMs in very early gestation could hugely increase women’s ability to independently control their fertility.
Dr Meg Thomas is a GP in Swindon, Wiltshire, and a fellow of the Faculty of Sexual and Reproductive Healthcare
Competing interests: none declared
Update on new methods