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Trial record 1 of 1 for:    NCT00443027
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Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. (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.
 
ClinicalTrials.gov Identifier: NCT00443027
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
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: September 2, 2008)
  • To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. [ Time Frame: 28d ]
  • To assess the safety and toleration of the heat washout device. [ Time Frame: 28d ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. To assess the safety and toleration of the heat washout device.
Change History Complete list of historical versions of study NCT00443027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle. [ Time Frame: 28d ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Official Title  ICMJE Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.
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 is 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 changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
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 three times 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)
12
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 healthy women aged 18-45 with regular, natural menstrual cycles.
  • Subjects must be void of Female Sexual Disorder.

Exclusion Criteria:

  • Pregnant or lactating women
  • Postmenopausal subjects
  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (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 NCT00443027
Other Study ID Numbers  ICMJE A9001303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
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