Oral lasofoxifene helps improve genitourinary syndrome of menopause

Oral lasofoxifene at either 0.25 or 0.5 mg daily confers benefits on genitourinary syndrome of menopause, with pooled data from two phase III trials showing significant improvements in vaginal signs or symptoms while having a favourable safety profile.

The two identical phase III trials involved postmenopausal women with moderate-to-severe vaginal symptoms. These women were randomly assigned to treatment with oral lasofoxifene 0.25 or 0.5 mg/d or placebo for 12 weeks.

The main outcomes of interest included changes from baseline to week 12 in the most bothersome symptom, vaginal pH, and percentages of vaginal parabasal and superficial cells. Analysis of covariance and nonparametric, rank-based Kruskal-Wallis test were applied in the analyses.

The pooled population comprised 889 women with an average age of 60 years. Those who received lasofoxifene showed significant improvements in all outcomes at week 12 compared with those who received placebo (p<0.0125 for all).

In the first trial, the most bothersome symptom was lower by a mean of 0.4 with 0.25-mg/d lasofoxifene and by a mean of 0.5 with the 0.5 mg/d dose versus placebo. Lasofoxifene was also associated with significantly lower vaginal pH (mean difference, −0.65 and −0.58, respectively), higher vaginal superficial cells (mean difference, 5.2 percent and 5.4 percent, respectively), and lower parabasal cells (−39.9 percent and −34.9 percent, respectively).

Results in the second trial were similar, with lasofoxifene being associated with significantly greater improvements in the most bothersome symptom (mean difference, −0.4 and −0.5, respectively), vaginal pH (mean difference, −0.57 and −0.67, respectively), vaginal superficial cells (mean difference, 3.5 percent and 2.2 percent, respectively), and parabasal superficial cells (mean difference, −34.1 percent and −33.5 percent, respectively). Some improvements occurred as early as week 2.

Treatment-emergent adverse events were mostly mild or moderate in severity, with hot flushes being the most frequently reported (lasofoxifene vs placebo: 13 percent to 23 percent vs 9 percent to 11 percent). Serious adverse events were rare, and there were no cases of deaths reported.