Trial Review

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/NCT00443027




Registration number
NCT00443027
Ethics application status
Date submitted
2/03/2007
Date registered
5/03/2007
Date last updated
28/05/2019

Titles & IDs
Public title
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Scientific title
Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.
Secondary ID [1] 0 0
A9001303
Universal Trial Number (UTN)
Trial acronym
HWO VBF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction, Physiological 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: Devices - Vaginal Heat Wash-Out Device

Experimental: Vaginal Heat Wash-Out Device -


Treatment: Devices: Vaginal Heat Wash-Out Device
No drug administered. Device tested three times with each subject.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
Timepoint [1] 0 0
28d
Primary outcome [2] 0 0
To assess the safety and toleration of the heat washout device.
Timepoint [2] 0 0
28d
Secondary outcome [1] 0 0
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Timepoint [1] 0 0
28d

Eligibility
Key inclusion criteria
- Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.

- Subjects must be void of Female Sexual Disorder.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or lactating women

- Postmenopausal subjects

- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or
neurologic disease.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Dulwich
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
5065 - Dulwich
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical
system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a
control unit. Output data is collected on a PC. By measuring the clearance of heat from the
heated probe, a direct measure of absolute blood flow can be obtained. The study will assess
changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00443027
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00443027