Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
FSAD HWO VBF
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.
1 other identifier
interventional
64
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 2, 2007
CompletedFirst Posted
Study publicly available on registry
March 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 28, 2019
May 1, 2019
1.6 years
March 2, 2007
May 23, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the safety and toleration of the heat washout device.
2 weeks
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
2 weeks
Secondary Outcomes (1)
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
2 weeks
Study Arms (1)
Vaginal Heat Wash-Out Device
EXPERIMENTALInterventions
No drug administered. Device tested twice with each subject.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Dulwich, South Australia, 5065, Australia
Pfizer Investigational Site
Nedlands, Western Australia, 6009, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2007
First Posted
March 5, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 28, 2019
Record last verified: 2019-05