Bijuve (estradiol/progesterone) is indicated as HRT for oestrogen deficiency symptoms in women at least 1 year after their last menses who have an intact uterus. The soft capsules are the first oral continuous combined body-identical estradiol/progesterone formulation to be available in the UK.
Dr Paula Briggs, incoming Chair of the British Menopause Society, said, 'We know women can be concerned about taking hormones and the impact they may have on their health beyond treating menopause symptoms. The availability of a body-identical progesterone which is well tolerated and has a lower risk profile than oral synthetic progestogens, combined with estradiol in a single capsule, is great news for women.
'As a healthcare community we should encourage our patients to reconsider the benefits of newer therapeutic options, allowing them to make informed choices.'
The bio-identical estradiol/progesterone combination was evaluated in a randomised, double-blind, phase III trial in postmenopausal women with vasomotor symptoms and a uterus. Of the 726 women eligible for the efficacy analysis, 141 were randomised to receive estradiol 1mg/progesterone 100mg, and 135 to receive placebo. Women included in the efficacy analysis had a mean age and BMI of 55 years and 27kg/m2, respectively; one third were African American.
Relief of menopausal symptoms was achieved during the first few weeks of treatment, with significant reductions in the number and severity of hot flushes in the estradiol 1mg/progesterone 100mg group compared with the placebo group at weeks 4 and 12 (p<0.05; primary efficacy endpoint). At week 4 the frequency of hot flushes was reduced by 40.6 points vs 26.4 points with placebo and the severity by 0.48 vs 0.34 points; corresponding reductions at week 12 were 55.1 vs 40.2 points and 1.12 vs 0.56 points.
Amenorrhea rates in women who received the hormone combination were high and generally consistent with those of approved HRT products.
In the 52-week safety analysis (n=280), endometrial biopsies taken at 12 months or at early trial discontinuation revealed a low incidence of endometrial proliferation (2.9%) and no cases of endometrial hyperplasia or endometrial cancer in women who received estradiol 1mg/progesterone 100mg.
The most commonly reported adverse drug reactions with the estradiol/progesterone combination in clinical trials were breast tenderness (10.4%), headache (3.4%), nausea (2.2%), pelvic pain (3.1%), vaginal haemorrhage (3.4%), and vaginal discharge (3.4%).