Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).

Pfizer64 enrolled

Overview

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 are 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 the technique's ability to differentiate between pre- and post-menopausal women; with and without Female Sexual Arousal Disorder (FSAD).

Medical Device Development

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Sexual Dysfunction, Physiological

Interventions

Vaginal Heat Wash-Out DeviceDEVICE

No drug administered. Device tested twice with each subject.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pre-menopausal women aged 18-40 (with and without FSAD) or * Post-menopausal women aged 50-65 (with and without FSAD. * FSAD must have been present for at least 6 months. Exclusion Criteria: * Pregnant or lactating women (pre-menopausal population) * Systemic Hormone Replacement Therapy (HRT) or Selective Estrogen Receptor Modulator (SERM) (postmenopausal population) * Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.

Locations (2)

Pfizer Investigational Site

Dulwich, South Australia, Australia

Pfizer Investigational Site

Nedlands, Western Australia, Australia

Outcomes

Primary Outcomes

To assess the safety and toleration of the heat washout device.

Time frame: 2 weeks

To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.

Time frame: 2 weeks

Secondary Outcomes

To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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