Here’s what two identically designed clinical trials with more than 1,200 women with HSDD who had not gone through menopause* showed:
Vyleesi increased sexual desire and reduced related distress.
Women who took Vyleesi experienced continued meaningful improvement of HSDD symptoms, with nearly 80% of women who completed the clinical study volunteering for an additional one-year extension.
The most common side effects are nausea, flushing, injection site reactions, headache, and vomiting.†
*The effectiveness and safety of Vyleesi were studied in two identical trials in over 1,200 women with HSDD who had not gone through menopause for at least six months. Ages ranged from 19-56 years old, with an average age of 39 years old; 86% were White and 12% were Black. The trials had two phases: a 24-week Core Study Phase (24-week placebo-controlled, double-blind treatment period) and an uncontrolled 52-week Open-label Extension Study Phase in which nearly 700 patients received Vyleesi. Most people who received Vyleesi used it two to three times per month and no more than once a week.
†Serious adverse reactions were reported in 1.1% of Vyleesi-treated patients and 0.5% of placebo-treated patients.
