PURPOSE: We evaluated the efficacy and safety of sildenafil citrate in spontaneously or surgically postmenopausal women with female sexual arousal disorder (FSAD). MATERIALS AND 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 protocolspecified 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 receivingestrogen and/or androgen replacement therapy.
RCT Entities:
PURPOSE: We evaluated the efficacy and safety of sildenafil citrate in spontaneously or surgically postmenopausal women with female sexual arousal disorder (FSAD). MATERIALS AND 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.
Authors: Crystal S Denlinger; Tara Sanft; K Scott Baker; Shrujal Baxi; Gregory Broderick; Wendy Demark-Wahnefried; Debra L Friedman; Mindy Goldman; Melissa Hudson; Nazanin Khakpour; Allison King; Divya Koura; Elizabeth Kvale; Robin M Lally; Terry S Langbaum; Michelle Melisko; Jose G Montoya; Kathi Mooney; Javid J Moslehi; Tracey O'Connor; Linda Overholser; Electra D Paskett; Jeffrey Peppercorn; M Alma Rodriguez; Kathryn J Ruddy; Paula Silverman; Sophia Smith; Karen L Syrjala; Amye Tevaarwerk; Susan G Urba; Mark T Wakabayashi; Phyllis Zee; Deborah A Freedman-Cass; Nicole R McMillian Journal: J Natl Compr Canc Netw Date: 2017-09 Impact factor: 11.908
Authors: Crystal S Denlinger; Robert W Carlson; Madhuri Are; K Scott Baker; Elizabeth Davis; Stephen B Edge; Debra L Friedman; Mindy Goldman; Lee Jones; Allison King; Elizabeth Kvale; Terry S Langbaum; Jennifer A Ligibel; Mary S McCabe; Kevin T McVary; Michelle Melisko; Jose G Montoya; Kathi Mooney; Mary Ann Morgan; Tracey O'Connor; Electra D Paskett; Muhammad Raza; Karen L Syrjala; Susan G Urba; Mark T Wakabayashi; Phyllis Zee; Nicole McMillian; Deborah Freedman-Cass Journal: J Natl Compr Canc Netw Date: 2014-02 Impact factor: 11.908