Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Sexual Arousal Disorder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Sildenafil 100 mg
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Study Period 1 or 2

Experimental: Experimental - Study Period 1 or 2

Treatment: Drugs: Sildenafil 100 mg

Treatment: Drugs: Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 30 minutes post-dose
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 60 minutes post-dose
Secondary outcome [2] 0 0
To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings.
Timepoint [2] 0 0
30 days post-dose
Secondary outcome [3] 0 0
Assess plasma levels of sildenafil and metabolite
Timepoint [3] 0 0
Day of dosing

Key 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
Minimum age
18 Years
Maximum age
45 Years
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Pfizer Call Center
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications