Status:
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Female Sexual Arousal Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00640458
Start Date
April 1 2004
End Date
March 1 2007
Last Update
February 1 2021
Active Locations (3)
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1
Pfizer Investigational Site
Seattle, Washington, United States, 98105
2
Pfizer Investigational Site
Seattle, Washington, United States, 98195-6465
3
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009