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Trial record 1 of 1 for:    NCT00443248
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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)

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ClinicalTrials.gov Identifier: NCT00443248
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : May 28, 2019
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 2, 2007
First Posted Date  ICMJE March 5, 2007
Last Update Posted Date May 28, 2019
Study Start Date  ICMJE March 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
  • To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
  • To investigate differences in vaginal blood flow following visual sexual stimulation in post-menopausal women with and without FSAD.
  • To assess the safety and toleration of the heat washout device.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Sexual Dysfunction, Physiological
Intervention  ICMJE Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested twice with each subject.
Study Arms  ICMJE Experimental: Vaginal Heat Wash-Out Device
Intervention: Device: Vaginal Heat Wash-Out Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 2, 2007)
64
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00443248
Other Study ID Numbers  ICMJE A9001302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP