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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
Genders 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
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Genital Diseases, Female
Genital Diseases, Male
Mental Disorders processed this record on May 24, 2016