Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.

Sexual Dysfunction, Physiological Clinical Trial

— HWO VBF  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443027
• Other study ID #: A9001303
• Status: Completed
• Phase: Phase 1
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Medical Device Development

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.

• Subjects must be void of Female Sexual Disorder.

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.

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological

Intervention

Device:
• Vaginal Heat Wash-Out Device
No drug administered. Device tested three times with each subject.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Dulwich	South Australia
Australia	Pfizer Investigational Site	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.		28d
Primary	To assess the safety and toleration of the heat washout device.		28d
Secondary	To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.		28d

External Links

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