A recent study published in the journal of Menopause revealed promising results for the treatment of moderate to severe vaginal atrophy in postmenopausal women using oral lasofoxifene. This research was conducted by Risa Kagan and team which included two phase 3, randomized, controlled trials that demonstrated the efficacy of lasofoxifene in reducing the symptoms associated with genitourinary syndrome of menopause (GSM).

The studies assessed whether lasofoxifene could improve the most bothersome symptoms (MBS) of GSM along with evaluating changes in vaginal pH and the percentages of vaginal parabasal and superficial cells. A total of 889 postmenopausal women with an average age of approximately 60 years participated in the trials. They were randomly assigned to receive either a daily dose of 0.25 mg or 0.5 mg of lasofoxifene or a placebo, over a 12-week period.
The participants who were receiving lasofoxifene showed significant improvements in all coprimary endpoints when compared to the placebo group. Also, the MBS decreased markedly with lasofoxifene 0.25 mg/d and 0.5 mg/d (least square mean difference from placebo: −0.4 and −0.5, respectively). Vaginal pH levels also dropped (−0.65, −0.58 for the lower dose and −0.57, −0.67 for the higher dose) which indicated a healthier vaginal environment. There was a notable increase in superficial cells and a reduction in parabasal cells which highlights the improvements in vaginal tissue health.

The benefits of lasofoxifene became apparent as early as week two of the treatment. The adverse effects were mostly mild to moderate, with hot flushes being the most frequently reported side effect (13%-23% for lasofoxifene versus 9%-11% for placebo). Also, serious adverse events were rare and no deaths were reported during course of this study.
The outcomes of this study concluded that lasofoxifene at both dosages provided significant and clinically meaningful improvements in the symptoms and signs of vaginal atrophy in postmenopausal women. The favorable safety profile of the drug further supports its potential as an effective treatment for GSM.
These findings offer new hope for postmenopausal women with vaginal atrophy which is a common yet often underreported condition that can significantly impact quality of life. The dual benefits of lasofoxifene in improving vaginal health and its manageable side effect profile make it a promising option for those seeking relief from GSM symptoms.
Reference:
Kagan, R., Simon, J. A., Goldstein, S. R., Komm, B. S., Jenkins, S. N., & Portman, D. J. (2024). Oral lasofoxifene’s effects on moderate to severe vaginal atrophy in postmenopausal women: two phase 3, randomized, controlled trials. In Menopause. Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/gme.0000000000002355