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Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-Menopausal Women With Female Sexual Arousal Disorder

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 17, 2008
Last updated: April 4, 2008
Last verified: April 2008
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.

Condition Intervention Phase
Female Sexual Arousal Disorder
Drug: Sildenafil 100 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome 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 ]

Secondary Outcome 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 ]
  • 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 ]
  • Assess plasma levels of sildenafil and metabolite [ Time Frame: Day of dosing ]

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: March 2007
Arms Assigned Interventions
Placebo Comparator: Placebo
Study Period 1 or 2
Drug: Placebo
Experimental: Experimental
Study Period 1 or 2
Drug: Sildenafil 100 mg


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   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.
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Please refer to this study by its identifier: NCT00640458

United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98105
Pfizer Investigational Site
Seattle, Washington, United States, 98195-6465
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00640458     History of Changes
Other Study ID Numbers: A1481174
Study First Received: March 17, 2008
Last Updated: April 4, 2008

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Pathologic Processes
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on May 25, 2017