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

NCT00640458 | Completed Phase 2

• 1 other identifier: A1481174
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Female Sexual Arousal Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Study Period 1 or 2

Drug: Placebo

Experimental

EXPERIMENTAL

Study Period 1 or 2

Drug: Sildenafil 100 mg

Interventions

Sildenafil 100 mg DRUG

Experimental

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (3)

Pfizer Investigational Site

Seattle, Washington, 98105, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98195-6465, United States

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Related Links

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

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2004
• Study Completion: March 1, 2007
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (2); AU (1)