A Systematic Review of Randomized Controlled Trials Investigating the Efficacy and Safety of Testosterone Therapy for Female Sexual Dysfunction in Postmenopausal Women

Channa N. Jayasena; Fatima M. Alkaabi; Curtis S. Liebers; Thomas Handley; Stephen Franks; Waljit S. Dhillo


Clin Endocrinol. 2019;90(3):391-414. 

In This Article

Abstract and Introduction


The clinical sequelae of oestrogen deficiency during menopause are undoubted. However, the pathophysiological role of testosterone during the menopause is less clear. Several randomized, placebo-controlled clinical trials suggest that testosterone therapy improves sexual function in postmenopausal women. Some studies suggest that testosterone therapy has additional effects, which include increased bone mineral density and decreased serum high-density lipoprotein (HDL) cholesterol. Furthermore, the long-term safety profile of testosterone therapy in postmenopausal women is not clear. This article will provide a concise and critical summary of the literature, to guide clinicians treating postmenopausal women.


Menopause is the cessation of menstruation and reproductive function, due to reduced ovarian activity. Menopause typically occurs between 45 and 55 years of age.[1]

Reduced circulating levels of oestrogen during menopause transition or perimenopause may cause hot flushes, low mood and symptoms of vulvovaginal atrophy.[2] The hallmark symptoms of menopausal transition/perimenopause are hot flushes and irregular periods, whereas amenorrhoea is required for menopause itself. Women may experience vaginal atrophy and vaginal dryness mostly in the late menopausal transition and even beyond.[2,3,4] Some women also experience decreased libido, receptivity and responsiveness, and reduced frequency of sexual thoughts and fantasies during menopause transition and postmenopause. It is estimated that 50%-60% of all postmenopausal women suffer from symptoms of urogenital and sexual dysfunction.[5,6]

Androgens are natural steroid hormones regulating the development and maintenance of classically male characteristics. However, women also depend on the physiological action of androgens which are thought to include regulation of libido and sexual arousal.[7] Androgens are synthesized in the testes, ovaries and adrenal glands.[8]

It is over 60 years since testosterone therapy was first reported in postmenopausal women.[9] There is currently growing interest in the role of testosterone therapy for the treatment of sexual dysfunction in postmenopausal women; however, prescribing behaviour is highly variable across the UK, which reflects uncertainty about the safety and effectiveness of therapy. This article aims to provide an objective summary of the evidence to date investigating the effectiveness and safety of testosterone replacement for sexual dysfunction in postmenopausal women.