A Phase 1 interventional study of Vaginal Heat Wash-Out Device in Sexual Dysfunction, Physiological, sponsored by Pfizer. Completed at 2 sites in Australia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Pfizer · Phase 1, Interventional, and Other
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.
Medical Device Development
115 studies on the registry are indexed under Sexual Dysfunction, Physiological; 46 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 80 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested three times with each subject.
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
Time frame: 28d
To assess the safety and toleration of the heat washout device.
Time frame: 28d
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Time frame: 28d
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Sexual Dysfunction, Physiological→
Pfizer