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

Tracking Information

First Received Date ^ICMJE

March 2, 2007

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00443027 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sexual Dysfunction, Physiological

Intervention ^ICMJE

Device: Vaginal Heat Wash-Out Device

Study Arms / Comparison Groups

No Intervention: Not Specified

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00443027

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A9001303

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP