Explaining the newly funded testosterone product

We are pleased to see Pharmac has announced full funding of a further form of transdermal testosterone treatment, Testogel. Existing funded testosterone preparations for (cis and trans) men are in the form of injection, capsule or patch form, whereas Testogel is a gel formulation which provides an additional transdermal (topical) option for men who need testosterone treatment.  Testogel is a well-researched product designed and studied for testosterone treatment in men who are testosterone deficient or seek gender-affirming hormone treatment.     

What does this mean for peri and post menopausal women?  

Testosterone is sometimes useful for symptoms of low libido in peri and postmenopausal women, and there are well-studied preparations designed specifically for women (see below).  Testogel is a preparation only designed for use in men.  As Reproductive Health Endocrinologists we do not routinely recommend that Testogel be used to provide testosterone treatment in women. 

When should testosterone be used in peri and post-menopause?  

We use testosterone treatment for peri and post-menopausal women, in addition to standard MHT (Menopausal Hormone Therapy, formerly known as HRT or Hormone Replacement Therapy), to help manage low libido (see our separate article about this). At present, international recommendations do not support using testosterone in cis women for other indications, as studies have not shown benefit for managing concerns such as poor sleep, low energy, reduced muscle strength, low mood or migraines.  

What formulation of testosterone is appropriate for women?  

In New Zealand and Australia, women have access to a non-funded testosterone cream called Androfeme.  Androfeme contains 1% testosterone and is well-researched and specifically developed to provide testosterone treatment to peri and post-menopausal women with hypoactive sexual desire disorder (HSDD).  There are studies showing that when used correctly, Androfeme delivers testosterone in doses that are safe and effective for women, and with dose-consistency.

The British Menopause Society comment on testosterone supplementation for women in their 2022 guideline: 
 

 “The recent licensing of 1% testosterone cream in Australia is an encouraging development; it is hoped that regulators in other countries may be encouraged by this enlightened approach by the Australian regulators who recognised the unmet need and the large body of evidence already available for testosterone in women.” 

Cautions with using testosterone preparations designed for men in women:  

Consistent delivery of appropriate and safe levels of testosterone is important because high testosterone levels in women may cause side effects such as unwanted body hair, acne, mood changes, aggression and very high levels can cause virilisation (development of male features such as changes in the voice, external genitals and musculature).  Serious risks of high testosterone levels include changes to lipids, tendency to blood clotting and vascular events (e.g. heart attack and stroke).   Prior to the availability of Androfeme in New Zealand, we used male testosterone replacement products at a modified dose and noticed side effects of acne, increased body hair and sometimes, clitoral enlargement. 

We see very few side effects from  Androfeme when used correctly, which includes using the provided applicator for dose measurement, and regular monitoring of blood levels of Testosterone.   In contrast to the body of evidence to support the use of Androfeme in women, there is only one small study   assessing Testogel use in 10 women; importantly this study used Testogel sachets (not the pump that has been funded in New Zealand, which may make it harder to measure out the optimal amount for women). 

Nonetheless, there may be times when specialists use medications “off label” or outside of existing guidelines; this is done in collaboration with the patient, weighing the potential benefits and risks of the treatment, and with awareness of a degree of uncertainty when there is a lack of data in that area.  

Summary and the gender-equity gap

We suggest a careful discussion with an appropriately qualified specialist for those who may be considering using Testogel in peri or post-menopause, as this is a product designed for and studied in men, and noting that there is an existing testosterone formulation on the market which has been designed for and studied in women.  

We note that in New Zealand there were already 4 fully funded options for testosterone treatment available for use in men: Sustenon, Reandron, Androderm patches and Testosterone Cipionate. This provides a gratifying number of options for male hormone treatment.  It is frustrating that women continue to experience limited choice for oestrogen treatment, exacerbated by a world-wide shortage of oestrogen patches and no funding for a second option for transdermal oestrogen treatment in women in the form of oestrogen gel, and no funded options for a testosterone formulation designed for women. 

We urgently need more MHT options for women.  We acknowledge the mahi  (work) of all our local and international colleagues in this space in continuing to address this important issue. The lack of funding for Androfeme is an example of an equity of access issue that we need to address locally and internationally.  

For more updates from us, and to help us raise awareness around issues relating to hormone-related health and  equity of access of safe and effective hormonal therapies, feel free to share this article and the link to our educational website erhassociates.co.nz, subscribe to our newsletter from the website and follow us on social media (@erhassociatesnz on Instagram, Linkedin and Facebook).   

Read our separate article on when to use testosterone in women here.  

Note: we do not have funded affiliations with manufacturers or distributors of Androfeme, Testogel, or any of the other treatments mentioned above. This article simply reflects our view based on our clinical experience as endocrinologists, reviewing of the literature and communications with international colleagues.