NCT00443248

Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).

A 2-Way Repeatability Study To Investigate Vaginal Blood Flow Before, During And After Visual Sexual Stimulation In Pre- And Post-Menopausal Women With And Without Female Sexual Arousal Disorder, Using The Heat Wash-Out Technique.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 are 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 the technique's ability to differentiate between pre- and post-menopausal women; with and without Female Sexual Arousal Disorder (FSAD).

Detailed description

Medical Device Development

Conditions

• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
DEVICE	Vaginal Heat Wash-Out Device	No drug administered. Device tested twice with each subject.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-05
• Last updated: 2019-05-28

Locations

2 sites across 1 country: Australia