{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T23:13:41Z","timestamp":1774134821275,"version":"3.50.1"},"reference-count":50,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T00:00:00Z","timestamp":1674432000000},"content-version":"vor","delay-in-days":1853,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2017,12,27]],"date-time":"2017-12-27T00:00:00Z","timestamp":1514332800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2018,1,3]],"date-time":"2018-01-03T00:00:00Z","timestamp":1514937600000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Emotional Brain BV, Almere, the Netherlands"}],"content-domain":{"domain":["jsm.jsexmed.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2018,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In women, low sexual desire and\/or sexual arousal can lead to sexual dissatisfaction and emotional distress, collectively defined as female sexual interest\/arousal disorder (FSIAD). Few pharmaceutical treatment options are currently available.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To investigate the efficacy and safety of 2 novel on-demand pharmacologic treatments that have been designed to treat 2 FSIAD subgroups (women with low sensitivity for sexual cues and women with dysfunctional over-activation of sexual inhibition) using a personalized medicine approach using an allocation formula based on genetic, hormonal, and psychological variables developed to predict drug efficacy in the subgroups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>497 women (21\u201370 years old) with FSIAD were randomized to 1 of 12 8-week treatment regimens in 3 double-blinded, randomized, placebo-controlled, dose-finding studies conducted at 16 research sites in the United States. Efficacy and safety of the following on-demand treatments was tested: placebo, testosterone (T;\u00a00.5 mg), sildenafil (S; 50 mg), buspirone (B; 10 mg) and combination therapies (T 0.25 mg\u00a0+ S 25 mg, T 0.25 mg\u00a0+ S 50 mg, T 0.5 mg\u00a0+ S 25 mg, T 0.5 mg\u00a0+ S 50 mg, and T 0.25 mg\u00a0+ B 5 mg, T 0.25 mg\u00a0+ B 10 mg, T 0.5 mg\u00a0+ B 5 mg, T 0.5 mg\u00a0+ B 10 mg).<\/jats:p><\/jats:sec><jats:sec><jats:title>Outcomes<\/jats:title><jats:p>The primary efficacy measure was the change in satisfying sexual events (SSEs) from the 4-week baseline to the 4-week average of the 8-week active treatment period after medication intake. For the primary end points, the combination treatments were compared with placebo and the respective monotherapies on this measure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In women with low sensitivity for sexual cues, 0.5 mg T\u00a0+ 50 mg S increased the number of SSEs from baseline compared with placebo (difference in change [\u0394]\u00a0= 1.70, 95% CI\u00a0= 0.57\u20132.84, P\u00a0= .004) and monotherapies (S: \u0394\u00a0= 1.95, 95% CI\u00a0= 0.44\u20133.45, P\u00a0= .012; T: \u0394\u00a0= 1.69, 95% CI\u00a0= 0.58\u20132.80, P\u00a0= .003). In women with overactive inhibition, 0.5 mg T\u00a0+ 10 mg B increased the number of SSEs from baseline compared with placebo (\u0394\u00a0=\u00a00.99, 95% CI\u00a0= 0.17\u20131.82, P\u00a0= .019) and monotherapies (B: \u0394\u00a0= 1.52, 95% CI\u00a0= 0.57\u20132.46, P\u00a0= .002; T:\u00a0\u0394\u00a0= 0.98, 95% CI\u00a0= 0.17\u20131.78, P\u00a0= .018). Secondary end points followed this pattern of results. The most common drug-related side effects were flushing (T\u00a0+ S treatment, 3%; T\u00a0+ B treatment, 2%), headache (placebo treatment, 2%; T\u00a0+ S treatment, 9%), dizziness (T\u00a0+ B treatment, 3%), and nausea (T\u00a0+ S treatment, 3%; T\u00a0+ B treatment, 2%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Implications<\/jats:title><jats:p>T\u00a0+ S and T\u00a0+ B are promising treatments for women with FSIAD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Strengths and Limitations<\/jats:title><jats:p>The data were collected in 3 well-designed randomized clinical trials that tested multiple doses in a substantial number of women. The influence of T\u00a0+ S and T\u00a0+ B on distress and the potentially sustained improvements after medication cessation were not investigated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>T\u00a0+ S and T\u00a0+ B are well tolerated and safe and significantly increase the number of SSEs in different FSIAD subgroups.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.jsxm.2017.11.226","type":"journal-article","created":{"date-parts":[[2017,12,27]],"date-time":"2017-12-27T22:37:56Z","timestamp":1514414276000},"page":"201-216","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":36,"title":["Efficacy and Safety of On-Demand Use of 2 Treatments Designed for Different Etiologies of Female Sexual Interest\/Arousal Disorder: 3 Randomized Clinical Trials"],"prefix":"10.1093","volume":"15","author":[{"given":"Adriaan","family":"Tuiten","sequence":"first","affiliation":[{"name":"Emotional Brain BV , Almere, \u00a0 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