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

Phase 2

Completed

• Conditions: Female Sexual Arousal Disorder
• Interventions: Drug: Placebo; Drug: Sildenafil 100 mg

• Registration Number: NCT00640458
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2007-03
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Study Period 1 or 2
Experimental	Sildenafil 100 mg	Study Period 1 or 2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.	30 days post-dose
Assess plasma levels of sildenafil and metabolite	Day of dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 Nedlands, Western Australia, Australia