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

A 2-Way Repeatability Study To Investigate Vaginal Blood Flow Before, During And After Visual Sexual Stimulation In Pre- And Post-Menopausal Women With And Without Female Sexual Arousal Disorder, Using The Heat Wash-Out Technique.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443248

Acronym

FSAD HWO VBF

Enrollment

Registered

2007-03-05

Start date

2007-03-31

Completion date

2008-10-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction, Physiological

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 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).

Detailed description

Medical Device Development

Interventions

DEVICEVaginal Heat Wash-Out Device

No drug administered. Device tested twice with each subject.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess the safety and toleration of the heat washout device.	2 weeks
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.	2 weeks

Secondary

Measure	Time frame
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.	2 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026