Please note that the ANZCTR website will be unavailable from 9am until 9.30am (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 ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00443027




Registration number
NCT00443027
Ethics application status
Date submitted
2/03/2007
Date registered
5/03/2007
Date last updated
27/05/2019

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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/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
Other publications