Here’s what two identically designed clinical trials with over 1,200 premenopausal women with HSDD* 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 premenopausal women with acquired, generalized HSDD 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.