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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seattle, Washington, 98105 United States
Contact
1-800-718-1021
ClinicalTrials.gov_[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Female Sexual Arousal Disorder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00640458
Pfizer
Completed
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

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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
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT00640458
A1481174
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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