Female testosterone cream gets tick of approval in win for gender and sexual equality

Associate Prof John Eden, WHRIA’s Reproductive Endocrinologist and Gynaecologist, comments on this exciting news.

“Over twenty years ago, our group along with Professor Sue Davis’s group in Melbourne performed the first studies with this product and now finally AndroFeme has been fully approved by the TGA and should be available April 2021, all around Australia. We have had “natural oestrogen” (oestradiol) available as tablets, gels and patches for many years. Prometrium (natural progesterone) has been available for about 5 years and now we have a female-appropriate testosterone product. The women of Australia now have all three natural sex hormones available and approved by the TGA.”
 
This is in contrast to compounded “bio-identical HRT” which does contain natural hormones too, but has not been produced or tested to a pharmaceutical standard, leading to potentially incorrect dosages and unnecessary side effects.
 
“I feel like one of my life goals has now been achieved, I have been working towards this moment for the last twenty years.”
 
Read the full media release from Lawley Pharmaceuticals below.

 

How will this help Australian women? 

Lawley Pharmaceuticals obtained approval on 20th November 2020 for registration of AndroFeme® 1 in the Australian Register of Therapeutic Goods (ARTG) for the treatment of postmenopausal women experiencing low sexual desire with associated personal distress, also known as hypoactive sexual desire dysfunction or HSDD. An estimated 1 in 3 Australian women aged 40 to 64 years experience HSDD. Australian postmenopausal women will now have access to a medically prescribed, clinically effective testosterone formulation which meets the requisite quality and safety standards for registration, for the management of HSDD.

For Perth-based Lawley Pharmaceuticals founder and CEO Michael Buckley, it is a decision that has been two decades in the making. “This is the first approval that addresses the need for a female-specific, regulated testosterone formulation for women.” Mr Buckley said. “It’s a ground-breaking decision for women across Australia, and hopefully in the near future, for women around the world.”

AndroFeme® 1 is a cream containing the hormone testosterone and is applied daily to the skin. The testosterone in AndroFeme® 1 is identical to the testosterone that the ovaries and adrenal glands would produce. Once applied the testosterone passes into the blood stream where it increases serum testosterone concentrations into the approximate physiological levels of premenopausal women.

Australian specialists and researchers have for decades pioneered ground-breaking research into female sexual dysfunction and testosterone use in women. This collective of work culminated in September 2019 with the release of the Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) which was endorsed by almost 20 of the world’s leading medical societies and associations.

The first author of the Global Position Statement is Australian Professor Susan Davis, endocrinologist and Director of Melbourne’s Monash Women’s Health Research Program.

“ There is irrefutable evidence that testosterone therapy, at a dose that results in premenopausal blood testosterone levels in postmenopausal women, can be highly effective for the treatment of postmenopausal women with low sexual desire and associated personal distress, or HSDD,” Professor Davis said.

“This is a global milestone in terms of gender equity, with the TGA being the first regulatory agency in the world to approve a treatment for sexual dysfunction for postmenopausal women”.

Since 1999, due to unique legislative differences between the State of Western Australia and the Commonwealth, AndroFeme® 1 has only been available for dispensing from WA-based pharmacies.

“This decision is a major step toward addressing the gender disparity in the treatment of sexual dysfunction that has existed for managing a very personal problem that is a source of significant distress for many women,” Mr Buckley said.

“The registration of AndroFeme® in the ARTG opens the door to international markets and Lawley Pharmaceuticals will actively be seeking out-licensing opportunities.”

AndroFeme® 1 is expected to be available in pharmacies nationally from April 2021.

For more information see our Health Information section for topics such as Body Identical Hormone Replacement Therapy, Menopause after Breast Cancer and many more.

 

Last updated: 16 December 2020

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