AndroFeme Provides Hormone Replacement For Women

Commonly considered the "manliness" hormone and associated with body hair, muscles and a deep voice, testosterone is actually key to female hormone balance. Women naturally produce testosterone in their ovaries and adrenal glands, but it begins to decline as a woman enters her 30s and beyond, and drops of steeply following menopause. Now, an Australian-based pharmaceutical company has created AndroFeme, a skin cream meant to restore testosterone levels in post-menopausal women.

"Men and women have the same hormones, just in difference quantities," said Michael Buckley, medical director and founder of Lawley Pharmaceuticals in Perth, Australia. "Men have mostly testosterone, but women are more complex because they have estrogen, progesterone and testosterone. The amount of each depends on where they are in their life cycle. It tends to be constant until their late 40s and early 50s, then declines rather rapidly."

The testosterone levels of a woman in her 40s are half those of a woman in her 20s. But testosterone levels can be brought back up to normal levels through hormone therapy. Some of the key benefits of testosterone for women's health include increased sex drive, bone density and breast health.

Despite these benefits, there is currently no Food and Drug Administration-approved testosterone product for women. Women in the U.S. can get a doctor's prescription for either off-label use of a male testosterone product or a custom formula made by a compounding pharmacy. Western Australia is currently the only country that has a testosterone product approved for women.

Buckley -- a pharmacist by profession -- and his company Lawley have developed a range of hormones identical to what the body produces. The skin cream, called AndroFeme, was recently the subject of a clinical trial to determine an appropriate standard dose to restore testosterone levels in post-menopausal women.

Traditional HRT is estrogen-based, and may or may not use progesterone depending on certain factors including whether the woman has had a hysterectomy or not. If they have had one, doctors tend to use estrogen. If they haven't, doctors prescribe estrogen and progesterone or its synthetic form.

"Unfortunately doctors in Australia and the States don't look at testosterone in women," said Buckley. "Some doctors who specialize in the field will test testosterone, but the vast majority won't. In the States, there is no testosterone product approved by the FDA for women."

Buckley said that this is probably because the main use of testosterone is to restore energy levels and libido. This hormone controls desire, arousal, orgasm and the whole range of sexual issues.

"The whole concept by regulators is that sexual function is not a disease state that needs to be treated," said Buckley. "If a woman's ovaries are removed or under radiotherapy, there is no testosterone, and no libido. But for younger women in relationships it can be a problem to have no energy or no sexual energy."

Women who may need testosterone could go to their doctor with symptoms and get a blood test to find the numbers of what their testosterone is. Buckley said that they may have a low libido and testosterone but still be in the normal range.

"There can also be other issues at play," he said. "A number of drugs like antidepressants and oral contraceptives can also have a significant affect on a woman's libido."

Patients use AndroFeme to get their hormones back to normal levels. Doctors should check levels after three weeks to a month.

"This is not a product for lifetime use," said Buckley. "Patients tend to use it for a year or two. This is one of those things that over time corrects itself. Engaging in sexual activity makes more testosterone, so it can be a 'use it or lose it' kind of thing: the more sexual activity you have, the more hormones it makes, until you're maintaining a continual production of testosterone."

In those cases where a woman's ovaries have been prophylactically removed to prevent ovarian or breast cancer, AndroFeme reduces menopausal symptoms.
Although AndroFeme is available overseas, it is not yet registered in the United States. And although it's one of the only companies that provides testosterone for women, Buckley advises that it should only be used under medical supervision.

"It's available via online pharmacies but I don't recommend people go it alone," said Buckley. "You should use this product under medical supervision. These are powerful hormones, and you should have regular blood tests."

But Buckley said in general, AndroFeme is safe. Australia banned the FDA-approved Methyl testosterone 30 years ago because it causes liver damage, which in his opinion the U.S. should have also banned. The only reason to use methyl is that it's in tablet form, which people like better than daily injections.

"The main thing is that this is meant to be used under medical supervision," said Buckley. "I don't recommend people self-medicate."