Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. (HWO VBF)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Sexual Dysfunction, Physiological

Treatments: Device: Vaginal Heat Wash-Out Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443027

A9001303

Details and patient eligibility

About

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.

Full description

Medical Device Development

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Vaginal Heat Wash-Out Device

Experimental group

Treatment:

Device: Vaginal Heat Wash-Out Device