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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
History of Changes

March 17, 2008
April 4, 2008
April 2004
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00640458 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Female Sexual Arousal Disorder
  • Drug: Sildenafil 100 mg
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Study Period 1 or 2
    Intervention: Drug: Placebo
  • Experimental: Experimental
    Study Period 1 or 2
    Intervention: Drug: Sildenafil 100 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2007
Not Provided

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00640458
A1481174
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP