Back to resultsEffect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. (HWO VBF)
Primary Purpose
Sexual Dysfunction, Physiological
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Vaginal Heat Wash-Out Device
Sponsored by
About this trial
This is an interventional other trial for Sexual Dysfunction, Physiological
Eligibility Criteria
Inclusion Criteria:
- Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
- Subjects must be void of Female Sexual Disorder.
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaginal Heat Wash-Out Device
Arm Description
Outcomes
Primary Outcome Measures
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
To assess the safety and toleration of the heat washout device.
Secondary Outcome Measures
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00443027
Brief Title
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Acronym
HWO VBF
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Heat Wash-Out Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vaginal Heat Wash-Out Device
Intervention Description
No drug administered. Device tested three times with each subject.
Primary Outcome Measure Information:
Title
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
Time Frame
28d
Title
To assess the safety and toleration of the heat washout device.
Time Frame
28d
Secondary Outcome Measure Information:
Title
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Time Frame
28d
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
Subjects must be void of Female Sexual Disorder.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Dulwich
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001303&StudyName=Effect%20Of%20Menstrual%20Cycle%20On%20Vaginal%20Blood%20Flow%20In%20Pre-Menopausal%20Healthy%20Women.
Description
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Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
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