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Completed

NCT Number: NCT00443027

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

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.

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Key information

Conditions

Sexual Dysfunction, Physiological Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Dulwich, South Australia, Australia

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About this study

Medical Device Development

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Heat Wash-Out Device

Device

No drug administered. Device tested three times with each subject.

Primary outcomes

  1. To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

    Time frame: 28d

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

    Time frame: 28d

Secondary outcomes

  1. To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.

    Time frame: 28d

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Acronym: HWO VBF

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2007
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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