Caruso et al. (2001)(9) Italy |
Premenopausal women diagnosed with FSAD (n=59) |
Randomized to 1 of 6 sequence possibilities with the three therapeutic regimens: placebo, 25 mg sildenafil, and 50 mg sildenafil. Each therapeutic regimen was 4 weeks long, with one week break between regimens. |
Personal Experience Questionnaire |
Arousal and orgasm improved with sildenafil compared to placebo (p<0.001). Frequency of fantasies, frequency of sexual intercourse, satisfaction with frequency, and overall satisfaction improved with sildenafil compared to placebo (p<0.005). |
Sildenafil can improve female arousal dysfunction as well as other aspects of female sexuality. |
2 |
Basson et al. (2002)(10) Canada |
Premenopausal /menopausal FSAD women with HRT (n=577) or postmenopausa l women without HRT (n=204) |
Sildenafil 10 mg (n=142) vs Sildenafil 50 mg (n=143) vs Sildenafil 100 mg (n=141) vs Placebo (n=151) for 12 weeks in premenopausa l/menopausal women with HRT Sildenafil 50 mg (n=103) vs Placebo (n=101) for 12 weeks in women without HRT |
Two global efficacy questions, event log, LSC and SFQ at the end of 12 weeks |
No statistically significant difference between sildenafil and placebo in the parameters evaluated in both premenopausal or menopausal women with HRT and postmenopausal women without HRT. |
Sildenafil in women with broad spectrum FSAD showed no efficacy. |
2 |
Basson and Brotto (2003)(11) Canada |
Postmenopaus al women with HRT for more than 6 months and diagnosed with FSAD (n=34) |
Sildenafil 50mg session one and Placebo session two (n=17) vs Placebo session one and Sildenafil 50mg session two (n=17) Sildenafil 50mg and Placebo 1 hour prior to a session - viewing a 30 min erotic movie while using a portable vibrator with direct clitoral stimulation of standard intensity for all women |
Latency to orgasm and questionnaire about the subjective intensity of orgasm and general sexual arousal |
The latency to reach orgasm was 1341 seconds with placebo and 1363 seconds with sildenafil (p>0.05). The mean intensity of orgasm was 5.8 with placebo and 6.5 with sildenafil (p>0.05). Neither the main effect of sildenafil (p>0.05) nor the main effect of placebo (p>0.05) reached statistical significance for the subjective intensity of orgasm and general sexual arousal. |
Sildenafil has no benefit in postmenopausal women on HRT and FSAD. |
2 |
Berman et al . (2003)(12) USA |
Postmenopaus al women on HRT for more than 3 months or hysterectomize d with FSAD and with or without HSDD (n=208) |
Sildenafil 50 mg (n=103) vs Placebo (n=105) for 12 weeks |
SFQ and FIEI |
FSAD+HSDD: no statistically significant differences between sildenafil and placebo. FSAD: sildenafil associated with improvement in all FIEI questions especially 2 - increased sensation in the genital area during intercourse (p=0.0004) and 4 - increased satisfaction with intercourse and/or foreplay (p=0.0001), as well as in the SFQ domains sensation of arousal (p<0.001), lubrication (p=0.003) and orgasm (p=0.01). |
Sildenafil was associated with significant improvements in sexual arousal, orgasm, inter- course and overall satisfaction with sexual life in postmenopausal women with FSAD without concurrent HSDD who had protocol specified estradiol and free testosterone concentrations or were receiving estrogen and/or androgen replacement therapy. |
2 |
Cavalcanti et al. (2008)(13) Brazil |
Postmenopaus al women diagnosed with FSD (n=22) |
Sildenafil 50 mg daily (n=11) vs Placebo for 15 days (n=11) |
GRISS and data on lubrication, clitoral sensitivity and orgasm |
The mean GRISS value had an increase with sildenafil of 9.47% compared to baseline (p<0.05) and 3.37% compared to placebo (p<0.05). Lubrication and clitoral sensitivity increased with sildenafil compared to baseline (p<0.05) and placebo (p<0.05). The intensity of orgasm increased by 64% and 18% in the sildenafil and placebo groups (p<0.05). |
Sildenafil may improve sexual response in postmenopausal women with FSD. |
2 |
Zeinalzadeh et al. (2017)(14) Iran |
Premenopausal women with FSD (n=84) |
Sildenafil 50 mg (n=42) vs Placebo (n=42) for 4 weeks |
FSFI |
The mean values of sexual desire (p=0.011), sexual arousal (p=0.001), lubrication (p=0.026), orgasm and sexual satisfaction (p<0.001) were higher with sildenafil. The mean values of sexual arousal, orgasm, sexual satisfaction and function (p<0.001) and sexual desire (p=0.001) were higher with sildenafil. |
Sildenafil was effective in increasing sexual desire, arousal, orgasm and sexual satisfaction. |
2 |