During menopause, your oestrogen levels can drop so low that they cause vaginal atrophy. This means that your vaginal tissue shrinks and thins, causing vaginal inflammation that can be exacerbated by sexual intercourse. This is known as dyspareunia, a widely-reported sexual wellness symptom that can make sex very painful and troublesome.
So how does the drug help? Osphena is an oestrogen agonist, which means that, as oestrogen does, it makes your vaginal tissues thicker and less fragile. This, in turn, alleviates the pain that women can experience during sex. The drug comes in the form of a once-a-day pill, to be taken with food, and Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Centre for Drug Evaluation and Research, said that the pill will finally provide relief for postmenopausal women who suffer from dyspareunia.
To assess the effectiveness of the drug, researchers carried out three different clinical studies which, in total, included 1,889 participants. These women, who all experienced symptoms of vulvar and vaginal atrophy, were randomly assigned to take either Osphena or a placebo. Whilst the first two trials showed that twelve weeks of the drug treatment helped women to find relief from dyspareunia, the results from the third trial identified the long-term safety of taking the drug.
However, that is not to say that Osphena is completely free of risk. Patients and doctors should be aware that the drug not only thickens vaginal tissue, but also the uterus. Usually, when you’re fertile, your experience stimulation and thickening of the uterus a month before menstruation, however, this isn’t normally likewise experienced by postmenopausal women.
There are other side effects associated with the drug, including vaginal discharge, muscle spasms, excessive sweating, genital discharge and hot flashes. Further, Osphena has been associated with an increased risk of endometrial cancer (0.72 per thousand women) and thrombotic or haemorrhagic stroke (1.45). However, this is relatively low, especially when compared to how oestrogen-alone therapy raises these same risks. It is advised that you only use Osphena for the shortest duration possible, consistent with your treatment goals.