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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Placebo comparator: Placebo - Study Period 1 or 2

Experimental: Experimental - Study Period 1 or 2
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00640458