Official Title: “A Double Blind, Placebo Controlled 2-Way Cross-Over Study to Assess the Clitoral Engorgement Response as Measured by Non-Contrast Magnetic Resonance Imaging (MRI) in Women With Female Sexual Arousal Disorder (FSAD) When Administered a Single Dose of Sildenafil (100mg) Followed by Audio/Visual Sexual Stimulation”

The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Sildenafil 100 mg
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • Study Period 1 or 2
• Experimental: Experimental
  • Study Period 1 or 2

Primary Measures

• To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD.
  • Time Frame: Up to 30 minutes post-dose
    Safety Issue?: No

Secondary Measures

• To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively.
  • Time Frame: Up to 60 minutes post-dose
    Safety Issue?: No
• To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.
  • Time Frame: 30 days post-dose
    Safety Issue?: No
• Assess plasma levels of sildenafil and metabolite
  • Time Frame: Day of dosing
    Safety Issue?: No

Inclusion Criteria:

• Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.

Exclusion Criteria:

• Subjects with hypoactive sexual desire disorder.
• Subjects not using an acceptable mean of contraception for the duration of the study.
• Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640458

Study ID Number: A1481174

ClinicalTrials.gov Identifier: NCT00640458

Health Authority: United States: Food and Drug Administration

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Link to ClinicalStudyResults.org posting