Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder.
OBJECTIVE
Sildenafil citrate (Viagra Pfizer, New York, NY) is indicated for the treatment of erectile dysfunction in men. The nitric oxide-cyclic guanosine monophosphate pathway (NO-cGMP) involved in penile erection and enhanced by sildenafil may also play a role in some components of the female sexual arousal response. The efficacy and safety of sildenafil were evaluated in estrogenized and estrogen-deficient women with sexual dysfunction that included female sexual arousal disorder (FSAD).


METHODS
Patients were randomized to receive 10-100 mg sildenafil or matching placebo. To assess efficacy, patients completed two global efficacy questions (GEQ), the Life Satisfaction Checklist (LSC), an event log of sexual activity, and a 31-item sexual function questionnaire (SFQ). To assess safety, adverse event (AE) data were recorded.


RESULTS
A total of 577 estrogenized and 204 estrogen-deficient women were randomized to treatment. All were diagnosed with FSAD, but it was the primary presenting symptom in only 46% and 50% of women, respectively. Differences in efficacy between sildenafil and placebo were not significant for any patient or partner end points (e.g., the two GEQ, the sexual event logs, the LSC, and the SFQ). The main AE were headache, flushing, rhinitis, nausea, visual disturbances, and dyspepsia, which were generally mild to moderate in nature.


CONCLUSIONS
Any genital physiological effect of sildenafil was not perceived as improving the sexual response in estrogenized or estrogen-deficient women with a broad spectrum of sexual dysfunction that included FSAD. Whether more specific subgroups of women with FSAD could potentially benefit from treatment with sildenafil is an area for future research.
Basson
Rosemary
R
Vancouver Hospital and Health Sciences Center, British Columbia, Canada.
McInnes
Rosemary
R
Smith
Mike D
MD
Hodgson
Gemma
G
Koppiker
Nandan
N
D000328:Adult; D000704:Analysis of Variance; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D004958:Estradiol / Q000172:deficiency; D015914:Estrogen Replacement Therapy; D005260:Female; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D011687:Purines; D012220:Rhinitis / Q000139:chemically induced; D012725:Sexual Behavior / Q000523:psychology; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D000068677:Sildenafil Citrate; D013223:Statistics as Topic / Q000379:methods; D013450:Sulfones; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D014786:Vision Disorders / Q000139:chemically induced
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D004958:Estradiol; D000068677:Sildenafil Citrate