Abstract | PURPOSE: 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:
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Authors | Jennifer R Berman, Laura A Berman, Steven M Toler, Jennifer Gill, Scott Haughie, Sildenafil Study Group |
Journal | The Journal of urology
(J Urol)
Vol. 170
Issue 6 Pt 1
Pg. 2333-8
(Dec 2003)
ISSN: 0022-5347 [Print] United States |
PMID | 14634409
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Phosphodiesterase Inhibitors
- Piperazines
- Purines
- Sulfones
- Testosterone
- Estradiol
- Sildenafil Citrate
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Topics |
- Adult
- Aged
- Double-Blind Method
- Estradiol
(blood)
- Female
- Humans
- Middle Aged
- Phosphodiesterase Inhibitors
(adverse effects, therapeutic use)
- Piperazines
(adverse effects, therapeutic use)
- Postmenopause
- Purines
- Sexual Behavior
- Sexual Dysfunctions, Psychological
(blood, drug therapy)
- Sildenafil Citrate
- Sulfones
- Testosterone
(blood)
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