Safety and efficacy of sildenafil citrate for the treatment of female sexual arousal disorder: a double-blind, placebo controlled study.
OBJECTIVE
We evaluated the efficacy and safety of sildenafil citrate in spontaneously or surgically postmenopausal women with female sexual arousal disorder (FSAD).


METHODS
Sildenafil (a 50 mg dose adjustable to 100 or 25 mg) was evaluated in a 12-week, double-blind, placebo controlled study in 202 postmenopausal women with FSAD who had protocol specified estradiol and free testosterone concentrations, and/or were receiving estrogen and/or androgen replacement therapy. Patients were excluded if emotional, relationship or historical abuse issues contributed significantly to sexual dysfunction. Primary end points were questions 2 (increased genital sensation during intercourse or stimulation) and 4 (increased satisfaction with intercourse and/or foreplay) from the Female Intervention Efficacy Index (FIEI). Secondary end points were the remaining questions from this index, the Sexual Function Questionnaire and sexual activity event log questions.


RESULTS
Significant improvements in FIEI questions 2 (p = 0.017) and 4 (p = 0.015) were noted with sildenafil compared with placebo. For women with FSAD without concomitant hypoactive sexual desire disorder (HSDD) sildenafil was associated with significantly greater improvement in 5 of 6 FIEI items compared with placebo (p <0.02). No significant improvements were shown for women with concomitant HSDD. Most adverse events were mild to moderate with headache, flushing, rhinitis, nausea and visual symptoms reported most frequently.


CONCLUSIONS
Sildenafil was effective and well tolerated in postmenopausal women with FSAD without concomitant HSDD or contributory emotional, relationship or historical abuse issues. All patients had protocol specified estradiol and free testosterone concentrations or were receiving estrogen and/or androgen replacement therapy.
Berman
Jennifer R
JR
Department of Urology, University of California-Los Angeles Medical Center, 90024, USA. JBerman@mednet.ucla.edu
Berman
Laura A
LA
Toler
Steven M
SM
Gill
Jennifer
J
Haughie
Scott
S
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D005260:Female; D006801:Humans; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D017698:Postmenopause; D011687:Purines; D012725:Sexual Behavior; D020018:Sexual Dysfunctions, Psychological / Q000097:blood / Q000188:drug therapy*; D000068677:Sildenafil Citrate; D013450:Sulfones; D013739:Testosterone / Q000097:blood
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D013739:Testosterone; D004958:Estradiol; D000068677:Sildenafil Citrate