Different to anything previously available here, the product which trades as Intrarosa will give GPs another option for managing a condition that causes distress and discomfort for a high percentage of postmenopausal women, says Dr Terri Foran, a Sexual Health Physician and lecturer at the School of Women’s and Children’s Health, UNSW.
Intrarosa was approved by the Therapeutic Goods Administration in June 2023, and is expected to be available in Australia from mid-2024. Each pessary contains 6.5 mg of prasterone, a synthetic form of dehydroepiandrosterone (DHEA).
DHEA is a steroid hormone precursor that can be converted into estrogens or androgens. As such, it offers a potential alternative to vaginal estrogen therapy, which is often considered the gold standard for maintaining vaginal skin thickness and secretions, Dr Foran says.
The DHEA is embedded in a waxy tablet that is inserted into the vagina each night, where it gets absorbed through the skin. “Enzymes within the cells turn the DHEA into what the cell requires – be that estrogens or androgens,” Dr Foran says. “It’s also broken up inside those skin cells. By the time they’re finished with it, about 95% of what’s been delivered is inactivated and secreted into the bloodstream.”
The manufacturer, Theramex, suggests Intrarosa may have benefits above and beyond those of estrogen, because receptors throughout the reproductive tract also have androgen receptors, Dr Foran says. However, she notes that these benefits are currently not as well documented in humans as they have been in animal models.
There are reasons for and against prescribing Intrarosa, Dr Foran says. On the plus side, levels of active hormone in the bloodstream are very low. “I think that’s going to appeal to women who would like to be on something that is effective but doesn’t lead to extra circulating hormones if they can avoid it,” she says.
Secondly, the waxes used in the delivery system are less likely to cause allergies, making it an alternative for women who are allergic to components in creams such as Ovestin.
Moreover, creams that contain active hormones require ongoing commitment rather than ad-hoc use to work. “I think sometimes women simply get sick of using them as often as needed to get the most out of the product,” Dr Foran says.
A potential downside of Intrarosa is that it needs to be used nightly, which requires an extra degree of commitment, Dr Foran says. This can also be advantageous, she adds, because applying a waxy product inside the vagina each night will have moisturising effects.
Importantly, it is not recommended for breast cancer survivors.
Several studies have shown that when administered over a 12-week period, intravaginal DHEA can significantly improve the signs and symptoms of vulvovaginal atrophy compared to placebo.
A phase III clinical trial studied the effect of a daily local application of 6.5 mg DHEA in 482 postmenopausal women. Women receiving treatment (n=325) had a significant improvement in vaginal skin health, secretions, pH and appearance compared to those in the placebo group (n=157). They also experienced significant improvements in pain with sex and vaginal dryness.
Another 12-week trial showed that intravaginal DHEA treatment can significantly improve libido and sexual function.
There may also be additional benefits over a longer term. In a phase III, open-label study, 521 postmenopausal women with vaginal atrophy received daily treatment with intravaginal prasterone for up to 52 weeks. In women with sex pain, there was a significant improvement in symptom severity after 12 weeks, with further improvement at 52 weeks.
Similar results were reported for vaginal dryness and irritation/itching, along with significant beneficial effects versus baseline on vaginal secretions, colour, and epithelial integrity and surface thickness.
Evidence aside, Dr Foran says prasterone’s biggest advantage is that is gives women with vaginal atrophy symptoms another treatment option. For those who don’t find available options acceptable or effective, she says you can suggest trying it to see whether it makes a difference. It is also an option for first line therapy in women of the right age who have vaginal atrophy symptoms and are not breast cancer survivors.
Firstly, though, vulvovaginal atrophy must be identified, and this can pose challenges. Dr Foran points out that by the age of 50 to 60, 50% of postmenopausal women experience symptoms of vaginal dryness. This figure rises to 72% by the age of 70. However, only about 7% of women in Australia use vaginal therapy, she says.
“And that makes no sense because it’s really safe. We know that women who use it get a significantly better quality of life, even if they’re not sexually active, and particularly if they are.”
Furthermore, symptoms like sexual pain and vaginal dryness tend to persist or worsen with time, Dr Foran says. “But often women are embarrassed to talk about it. And often it’s the case that if you don’t ask, people won’t tell you.”
She says some women may think symptoms are a normal part of aging. “And I think we need to tell them that, yes, it is normal. But you don’t have to put up with unpleasant symptoms.”
Dr Foran adds that older women presenting with frequent urinary tract infections may also benefit from treatment for vaginal atrophy.
Other things that may help include vaginal moisturisers for dryness and lubricants to make penetrative sex more comfortable.
Intrarosa is not on the PBS and will carry a recommended retail price of $39.99 for a 28-day supply.
*Dr Foran chaired the medical advisory board meeting for Theramex last year prior to Intrarosa’s registration in Australia.
Editor’s note: This article was written independently with no involvement or review from Theramex.
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