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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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, Usin

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 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 Summary: Medical Device Development
Sponsor: Pfizer

Current Primary Outcome:

  • To assess the safety and toleration of the heat washout device. [ Time Frame: 2 weeks ]
  • To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD. [ Time Frame: 2 weeks ]


Original Primary Outcome:

  • To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
  • To investigate differences in vaginal blood flow following visual sexual stimulation in post-menopausal women with and without FSAD.
  • To assess the safety and toleration of the heat washout device.


Current Secondary Outcome: To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. [ Time Frame: 2 weeks ]

Original Secondary Outcome: To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.

Information By: Pfizer

Dates:
Date Received: March 2, 2007
Date Started: March 2007
Date Completion:
Last Updated: February 6, 2009
Last Verified: February 2009