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

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

64 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 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).

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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 twice with each subject.

Interventions

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Vaginal Heat Wash-Out Device

No drug administered. Device tested twice with each subject.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes