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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Medical Device Development

Conditions

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Sexual Dysfunction, Physiological

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vaginal Heat Wash-Out Device

Group Type EXPERIMENTAL

Vaginal Heat Wash-Out Device

Intervention Type DEVICE

No drug administered. Device tested three times with each subject.

Interventions

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Vaginal Heat Wash-Out Device

No drug administered. Device tested three times with each subject.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes