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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00640458

Purpose

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 II

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

MedlinePlus related topics: MRI Scans Menopause

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Assess plasma levels of sildenafil and metabolite [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	April 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
Placebo: Placebo Comparator Study Period 1 or 2	Drug: Placebo
Experimental: Experimental Study Period 1 or 2	Drug: Sildenafil 100 mg

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640458

Locations

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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481174
Study First Received:	March 17, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00640458 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Sexual Dysfunctions, Psychological
Vasodilator Agents
Hyperemia
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological

Mental Disorders
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Menopause

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Disease
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Genital Diseases, Male

Sexual and Gender Disorders
Pharmacologic Actions
Genital Diseases, Female
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Pathologic Processes
Mental Disorders
Therapeutic Uses

ClinicalTrials.gov processed this record on September 10, 2009