Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00443027

Purpose

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
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.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Menstruation

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. [ Time Frame: 28d ] [ Designated as safety issue: No ]
To assess the safety and toleration of the heat washout device. [ Time Frame: 28d ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle. [ Time Frame: 28d ] [ Designated as safety issue: No ]

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
Not Specified: No Intervention Not Specified	Device: Vaginal Heat Wash-Out Device No drug administered. Device tested three times with each subject.

Detailed Description:

Medical Device Development

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443027

Locations

Australia, South Australia
Pfizer Investigational Site
Dulwich, South Australia, Australia, 5065
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 22, 2009