MHRA approves testosterone cream for UK postmenopausal women

MHRA approves testosterone cream for UK postmenopausal women

12 August 2025

Perth, Australia and Guildford, England:

Lawley Pharmaceuticals and its commercial partner in the UK, Andro Pharmaceuticals Ltd, are pleased to announce that Marketing Authorisation (MA) for AndroFeme® Cream 10mg/ml (testosterone) for postmenopausal women was approved by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on 25^th July 2025.

AndroFeme® 1 Cream 10mg/ml, a female specific testosterone formulation, is already licensed by Australian regulatory authorities since 2020 for the management of hypoactive sexual desire dysfunction (“HSDD”) in postmenopausal women.

HSDD is characterised by the loss or absence of sexual desire associated with personal distress which affects between 6-13% of women in Europe¹.

Lawley appointed Andro Pharmaceuticals Ltd as its exclusive licensee and distributor in England, Scotland and Wales for AndroFeme® Cream 10mg/ml in 2022.

The UK AndroFeme® SPC and PIL can be viewed at https://products.mhra.gov.uk/

Lawley’s founder and Medical Director, Michael Buckley, said ‘It is very pleasing that after many years postmenopausal women in the UK will soon have access to a female-specific testosterone formulation that is titratable to individual menopause needs.’

The United Kingdom is the fourth country to licence AndroFeme® after Australia, New Zealand and South Africa (TestaFeme®).

It is anticipated the UK approved product will be launched during 2026.

About ANDROFEME® Cream 10mg/ml (testosterone):

ANDROFEME® Cream 10mg/ml (testosterone) is a cream containing 1% w/v (10mg/ml) testosterone B.P (17-β- Hydroxyandrost-4-en-3-one). This form of testosterone is identical to the testosterone produced by the ovaries of women and the testes of men.

About Testosterone and Hypoactive Sexual Desire Dysfunction (HSDD): 

Testosterone is the primary hormone that is vital for sexual motivation and desire. Although it is commonly considered as a male hormone, testosterone is also produced by women in much smaller amounts by the ovaries and adrenal glands.

A reduction in or an absence of sexual desire, thoughts, fantasies, responsiveness to erotic cues or stimulation is very common in menopause and perimenopause women over the age of 40 years. Medically any of the above symptoms that have persisted over several months or more with associated distress is classified as hypoactive sexual desire dysfunction (HSDD). Clinical studies have shown that testosterone therapy for postmenopausal women with HSDD and low levels of testosterone can be useful to increase desire and sexual satisfaction.²

About Lawley Pharmaceuticals:

Lawley Pharmaceuticals is an Australian company that specialises in the manufacture of pharmaceutical grade body-identical testosterone creams for the treatment of various endocrine deficiencies and related medical conditions.

Please direct all enquiries to Michael Buckley, Medical Director, via michaelb@lawleypharm.com.au

End of Release.

References:

[1]. Nappi R et al. Management of hypoactive sexual desire disorder in women: current and emerging therapies. Int J Women’s Health. 2010; 2: 167-175.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2971736/ 

[2]. Islam, R. M. et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol 2019;7(10): 754-766.