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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00640458
First received: March 17, 2008
Last updated: April 4, 2008
Last verified: April 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ 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 Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Hyperemia
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 01, 2014