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

Female Sexual Arousal Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640458
• Other study ID #: A1481174
• Status: Completed
• Phase: Phase 2
• Start date: April 2004
• Est. completion date: March 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Sexual Arousal Disorder
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Sildenafil 100 mg

• Placebo

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Nedlands	Western Australia
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 30 minutes post-dose
Secondary	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.		Up to 60 minutes post-dose
Secondary	To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.		30 days post-dose
Secondary	Assess plasma levels of sildenafil and metabolite		Day of dosing

External Links

•   To obtain contact information for a study center near you, click here.