Back to resultsVaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)). (FSAD HWO VBF)
Primary Purpose
Sexual Dysfunction, Physiological
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Vaginal Heat Wash-Out Device
Sponsored by
About this trial
This is an interventional other trial for Sexual Dysfunction, Physiological
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaginal Heat Wash-Out Device
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and toleration of the heat washout device.
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
Secondary Outcome Measures
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00443248
Brief Title
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Acronym
FSAD HWO VBF
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Medical Device Development
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Heat Wash-Out Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vaginal Heat Wash-Out Device
Intervention Description
No drug administered. Device tested twice with each subject.
Primary Outcome Measure Information:
Title
To assess the safety and toleration of the heat washout device.
Time Frame
2 weeks
Title
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 Measure Information:
Title
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Dulwich
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001302
Description
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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)).
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