Data presented at the European Society of Contraception and Reproductive Health meeting in The Hague suggests Bayer's Qlaira could be an effective therapy for women suffering from heavy and/or prolonged periods.

Qlaira was launched in Europe in 2009 and is the first in class of combined oral contraceptives to use an estradiol valerate/dienogest combination. Estradiol valerate is metabolised to produce estradiol, which is identical to that produced by a woman and Bayer markets Qlaira as the first oral contraceptive (OC) based on natural estradiol (it has just been approved in the USA where it will be sold as Natazia).

Registration studies suggested that women on Qlaira have shorter, lighter bleeds than the comparator OC Miranova (ethinyl estradiol) so the company set up two Phase III studies investigating it as a treatment for heavy, prolonged periods. Presenting data from the European/Australia trial based on 177 women suffering from heavy periods not due to underlying disease, Diana Mansour, clinical director for sexual health services at Newcastle and North Tyneside said this is the first evidence from rigorous randomised trials of an oral contraceptive in the treatment for heavy menstrual bleeding which can have a significant impact on quality of life."

Results showed a "dramatic reduction in blood loss", with 79.2% of Qlaira users experiencing a significant fall in blood loss compared to 7.4% of those on placebo. It also halved the median drop in bleeding days over the 90-day reference period.

Dr Mansour reported a low incidence of adverse and serious adverse events with no unexpected drug reactions. The rate of withdrawal from treatment was 9.7% versus 6.2% for Qlaira and placebo, respectively. The US trial showed similar results.

Bayer has applied to extend its licence to include a second indication for Qlaira in the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire contraception.
By Rhonda Siddall