Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience 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 ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00640458




Registration number
NCT00640458
Ethics application status
Date submitted
17/03/2008
Date registered
21/03/2008
Date last updated
1/02/2021

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
A1481174
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
dyspareunia.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
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
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00640458
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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