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

Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443027

Acronym

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 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.

Detailed description

Medical Device Development

Interventions

DEVICEVaginal Heat Wash-Out Device

No drug administered. Device tested three times 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 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.	28d
To assess the safety and toleration of the heat washout device.	28d

Secondary

Measure	Time frame
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.	28d

Countries

Australia

Outcome results

None listed

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