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Theramex pioneers new treatment for post-menopausal women

Published on 24/09/21 at 12:48pm

Theramex has recently launched the first and only body-identical hormone therapy treatment (HRT) for post-menopausal women, in the form of Bijuva/Bijuve® (estradiol and progesterone).

Bijuva/Bijuve will be used for oestrogen deficiency symptoms in post-menopausal women with an intact uterus and at least 12 months since the last menses. It can be taken through a single capsule, which has been shown to be effective and well-tolerated. The estradiol and progesterone found in Bijuva/Bijuve are chemically and biologically identical to the natural hormones circulating in the woman’s body, marking its difference from synthetic hormone products.

Throughout the long-term, Phase III clinical trial, the safety of Bijuva/Bijuve was studied over 12 months of treatment, and demonstrated endometrial protection, as well as no significant changes in lipid, coagulation or glucose parameters as compared to placebo.

NICE and the British Menopause Society approved real-world evidence that suggests the use of body-identical hormones is associated with lower risks and fewer side effects compared to synthetic versions. The evidence demonstrates that body-identical hormones have not been shown to increase the risk of venous thromboembolism and are safer forms of HRT.

During menopause, women can experience numerous undesirable symptoms including vasomotor symptoms (VMS) such as hot flushes and night sweats. Other symptoms include sleep deprivation, inability to concentrate and stiffness of joints and muscles. These typically last around four years, but can last up to 12 years post-menopause in around 10% of women.

Bijuva/Bijuve has the potential to increase the quality of life for menopausal women experiencing moderate to severe vasomotor symptoms – in the long-term phase III clinical trial, Bijuva/Bijuve demonstrated significant improvement in sleep without causing fatigue.

Dr Paula Briggs, incoming Chair of the British Menopause Society, commented: “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.”

Lina Adams


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