Qlaira approved for heavy menstrual bleeding

Qlaira (estradiol valerate + dienogest), the first combined oral contraceptive (COC) to use an oestrogen component other than ethinylestradiol, has had its licence extended to include the treatment of heavy menstrual bleeding (HMB) in women without organic pathology who desire oral contraception.

Two multicentre, double-blind trials were performed to evaluate the efficacy and safety of Qlaira in women with HMB. In total, 269 women were randomised to Qlaira and 152 to placebo. After 6 months of treatment, median menstrual blood loss had decreased by 88% in the Qlaira group (from 142ml to 17ml) compared with a reduction of 24% in the placebo group (from 154ml to 117ml). Almost a third (29%) of women receiving Qlaira were completely cured of all HMB symptoms, compared with only 2% of those in the placebo group.

HMB is defined by NICE as ‘excessive menstrual blood loss which interferes with the woman’s physical, emotional, social and material quality of life’. NICE recommends COCs as a second-line option for the treatment of HMB, after the levonorgestrel-releasing intrauterine system (Mirena).

View Qlaira drug record

Further information: Bayer

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