Overview

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

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Sildenafil Citrate
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.