Efficacy and Safety of On-Demand Use of 2 Treatments Designed for Different Etiologies of Female Sexual Interest/Arousal Disorder: 3 Randomized Clinical Trials

• DOI: 10.1016/j.jsxm.2017.11.226
• Publication Date: 2017-12-27T22:37:56Z
• Authors: Adriaan Tuiten; Kim van Rooij; Jos Bloemers; Christoph Eisenegger; Jack van Honk; Rob Kessels; Sheryl Kingsberg; Leonard R. Derogatis; Leo de Leede; Jeroen Gerritsen; Hans P.F. Koppesc...; Berend Olivier; Walter Everaerd; Henderik W. Frijlink; Daniël Höhle; Robert P.J. de Lange; Koen B.E. Böcker; James G. Pfaus
• Keywords: Sexual arousal

Abstract Background In women, low sexual desire and/or arousal can lead to dissatisfaction and emotional distress, collectively defined as female interest/arousal disorder (FSIAD). Few pharmaceutical treatment options are currently available. Aim To investigate the efficacy safety of 2 novel on-demand pharmacologic treatments that have been designed treat FSIAD subgroups (women with sensitivity for cues women dysfunctional over-activation inhibition) using a personalized medicine approach an allocation formula based on genetic, hormonal, psychological variables developed predict drug in subgroups. Methods 497 (21–70 years old) were randomized 1 12 8-week regimens 3 double-blinded, randomized, placebo-controlled, dose-finding studies conducted at 16 research sites United States. Efficacy following was tested: placebo, testosterone (T; 0.5 mg), sildenafil (S; 50 buspirone (B; 10 mg) combination therapies (T 0.25 mg + S 25 mg, T B 5 mg). Outcomes The primary measure change satisfying events (SSEs) from 4-week baseline average active period after medication intake. For end points, compared placebo respective monotherapies this measure. Results cues, increased number SSEs (difference [Δ] = 1.70, 95% CI 0.57–2.84, P .004) (S: Δ 1.95, 0.44–3.45, .012; T: 1.69, 0.58–2.80, .003). overactive inhibition, (Δ 0.99, 0.17–1.82, .019) (B: 1.52, 0.57–2.46, .002; 0.98, 0.17–1.78, .018). Secondary points followed pattern results. most common drug-related side effects flushing treatment, 3%; 2%), headache (placebo 2%; 9%), dizziness 3%), nausea 2%). Clinical Implications promising FSIAD. Strengths Limitations data collected well-designed clinical trials tested multiple doses substantial women. influence distress potentially sustained improvements cessation not investigated. Conclusions well tolerated safe significantly increase different