- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443027
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. (HWO VBF)
May 23, 2019 updated by: Pfizer
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Medical Device Development
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Australia
-
Dulwich, South Australia, Australia, 5065
- Pfizer Investigational Site
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Pfizer Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaginal Heat Wash-Out Device
|
No drug administered.
Device tested three times with each subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
Time Frame: 28d
|
28d
|
To assess the safety and toleration of the heat washout device.
Time Frame: 28d
|
28d
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Time Frame: 28d
|
28d
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
March 2, 2007
First Submitted That Met QC Criteria
March 2, 2007
First Posted (Estimate)
March 5, 2007
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A9001303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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