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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00443027 |
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.
Condition | Intervention | Phase |
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Sexual Dysfunction, Physiological |
Device: Vaginal Heat Wash-Out Device |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 12 |
Study Start Date: | March 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Not Specified: No Intervention
Not Specified
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Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested three times with each subject.
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Medical Device Development
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Australia, South Australia | |
Pfizer Investigational Site | |
Dulwich, South Australia, Australia, 5065 | |
Australia, Western Australia | |
Pfizer Investigational Site | |
Nedlands, Western Australia, Australia, 6009 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9001303 |
Study First Received: | March 2, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00443027 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Genital Diseases, Female Sexual Dysfunction, Physiological Healthy Genital Diseases, Male Menopause |
Genital Diseases, Female Sexual Dysfunction, Physiological Genital Diseases, Male |