Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Phase 1
Completed
- Conditions
- Sexual Dysfunction, Physiological
- Interventions
- Device: Vaginal Heat Wash-Out Device
- Registration Number
- NCT00443027
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Medical Device Development
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
Inclusion Criteria
- Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
- Subjects must be void of Female Sexual Disorder.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaginal Heat Wash-Out Device Vaginal Heat Wash-Out Device -
- Primary Outcome Measures
Name Time Method To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. 28d To assess the safety and toleration of the heat washout device. 28d
- Secondary Outcome Measures
Name Time Method To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle. 28d
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇦🇺Nedlands, Western Australia, Australia