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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 2, 2007
Last updated: February 6, 2009
Last verified: February 2009
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).

Condition Intervention Phase
Sexual Dysfunction, Physiological Device: Vaginal Heat Wash-Out Device Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. [ Time Frame: 2 weeks ]

Estimated Enrollment: 64
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Not Specified
Not Specified
Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested twice with each subject.

Detailed Description:
Medical Device Development

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00443248

Australia, South Australia
Pfizer Investigational Site
Dulwich, South Australia, Australia, 5065
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00443248     History of Changes
Other Study ID Numbers: A9001302
Study First Received: March 2, 2007
Last Updated: February 6, 2009

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female processed this record on August 18, 2017