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Archive for October, 2017

What with slow but steady treatments for menopausal issues trickling into the marketplace (OsphenaDuavee and Brisdelle, for example), my toolkit is getting bulky. That’s good news.

Now another pharmaceutical option is on the market. The FDA approved Intrarosa last year for treating “moderate to severe pain during sexual intercourse (dyspareunia)” caused by thinning and drying of vaginal tissue during menopause. It’s been distributed in the US by AMAG Pharmaceuticals since July 2017.

Intrarosa is an interesting drug. It’s a synthetic version of a steroid naturally produced in our adrenal glands, called prasterone or dehydroepiandrosterone (DHEA). Prasterone is considered a “precursor hormone” because it is inactive until it comes in contact with vaginal (or other) cells, where it stimulates the production of both estrogen and testosterone. By interacting with vaginal cells to produce estrogen, elasticity and pH levels in vaginal tissue are improved, ideally making sex less painful.

If the term DHEA rings a bell, that’s because it’s commonly used as a nutritional supplement made from wild yam and soy. Sometimes called the “youth hormone,” DHEA is said to improve aging skin, aid in weight loss, and improve mood, among other health claims. While DHEA has been studied for many years, data on dosage or long-term safety haven’t been established.

Intrarosa is a suppository inserted into the vagina once daily at bedtime where it dissolves overnight. The effectiveness of Intrarosa was tested in two, 12-week trials of 406 women between the ages of 40 and 80 who had troubling symptoms of dyspareunia. They were randomly assigned to receive either Intrarosa or a placebo. Two additional 12-week trials and one year-long trial attempted to establish the safety and side effects of Intrarosa, according to the FDA press release.

Clinical trials support the effectiveness of Intrarosa, and FDA approval has been a high bar: “Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse,” said Audrey Gassman, MD, FDA spokesperson. One source said that Intrarosa seemed about as effective as a very low-dose topical estrogen.

Side effects appear to be relatively mild: six percent of women experienced vaginal discharge, which could be related to suppository itself, and a very few experienced abnormal Pap tests, the significance of which is unknown. Intrarosa doesn’t come with a black-box warning, and there is no warning against using it with breast cancer patients, which we’re happy about (it hasn’t yet been specifically trialed with that population). However, blood levels of circulating estrogen after taking Intrarosa were “below the threshold” of a post-menopausal woman.

Currently, AMAG Pharmaceuticals is offering an introductory program to “commercially qualified customers” of a zero-dollar copay for the first prescription and no higher than a $25-dollar copay for refills during the initial launch. After that, it’s anyone’s guess. Because vaginal cells tend to regenerate quickly, you should know within a few days to a couple of weeks whether Intrarosa will work for you.

Painful sex caused as a condition of menopause is incredibly common. Aggregating the data from many surveys indicates that about 32 million women have some symptoms of vulvovaginal atrophy. Of those, between 45 and 80 percent—quite a range, obviously—report having painful intercourse. Half of those women say they aren’t seeking treatment for it. You do the math. I’m just saying that in my experience, painful sex follows menopause like spring follows winter.

So, having another treatment option makes me happy. Is Intrarosa the magic bullet we’ve all been hoping for? Time will tell! I’ve been prescribing this fairly frequently already. If you suffer from dyspareunia, a conversation with your doctor about the potential risks and benefits of Intrarosa would be worthwhile. I’m interested to explore its effects with vulvodynia and the testosterone component. It’s a solid option with relatively low risk that may help many women.

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