Placebo-controlled study on efficacy and safety of daily apomorphine SL intake in premenopausal women affected by hypoactive sexual desire disorder and sexual arousal disorder

Objectives. To verify whether apomorphine SL is effective in premenopausal women affected by arousal disorder with hypoactive sexual desire disorder. Methods. Sixty-two volunteer women, aged 26 to 45 years, affected by arousal disorders and hypoactive sexual desire disorder participated in the study, which consisted of two parts. The first was 4 weeks of a taken-as-needed, open-label, dose-escalation regimen starting at 2 or 3 mg of apomorphine SL. The second part of the study was for the nonresponders, who were randomly allocated to treatment in one of six possible sequences of three 2-week double-blind, crossover study periods with apomorphine 2 mg or 3 mg, washout, and placebo. Efficacy was assessed with the Personal Experiences Questionnaire using the 5-point Likert scale. The Personal Experiences Questionnaire quantified subjective arousal, desire, orgasm, enjoyment, and frequency of sexual relationships. Results. Fifty women completed the 4-week "as required" drug regimen, and 6 of them benefited from this treatment regimen (P < 0.05). The 44 women who reported no change with respect to baseline participated in the double-blind crossover part of the study. Six women stopped taking the drug because of a fear of problems (two each during the 2-mg apomorphine, 3-mg apomorphine, and placebo periods). Adverse events were mild or moderate, both occurred during the "as required" part (10 patients) and during daily usage (6 patients) and were mainly nausea, vomiting, dizziness, or headache. However, during the placebo period, 2 women had adverse events, mainly headache. The daily intake of the drug was effective with both the 2-mg and 3-mg, dosages compared with placebo for arousal and desire (P < 0.05). The effects of 3 mg of apomorphine were better than those obtained with 2 mg (P < 0.05). The orgasm, enjoyment, and satisfied by frequency scores improved during treatment with daily apomorphine compared with baseline and placebo. Conclusions. The results of our study suggest that daily apomorphine SL may improve the sexual life of women affected by sexual difficulties. Additional studies are needed to define the daily use of apomorphine SL in large subgroups of women on the basis of etiology and the severity of sexual dysfunction. (C) 2004 Elsevier Inc.