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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443248
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : February 10, 2009
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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).

Condition or disease Intervention/treatment Phase
Sexual Dysfunction, Physiological Device: Vaginal Heat Wash-Out Device Phase 1

Detailed Description:
Medical Device Development

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
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.
Study Start Date : March 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Arm Intervention/treatment
No Intervention: Not Specified
Not Specified
Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested twice with each subject.

Primary Outcome Measures :
  1. To assess the safety and toleration of the heat washout device. [ Time Frame: 2 weeks ]
  2. 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 :
  1. To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00443248     History of Changes
Other Study ID Numbers: A9001302
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female