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Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. (HWO VBF)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00443027
First received: March 2, 2007
Last updated: February 6, 2009
Last verified: February 2009
History of Changes

March 2, 2007
February 6, 2009
March 2007
October 2008   (final data collection date for primary outcome measure)
  • To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation. [ Time Frame: 28d ] [ Designated as safety issue: No ]
  • To assess the safety and toleration of the heat washout device. [ Time Frame: 28d ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00443027 on ClinicalTrials.gov Archive Site
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle. [ Time Frame: 28d ] [ Designated as safety issue: No ]
To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
Not Provided
Not Provided
 
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
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.

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.

Medical Device Development
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Sexual Dysfunction, Physiological
Device: Vaginal Heat Wash-Out Device
No drug administered. Device tested three times with each subject.
No Intervention: Not Specified
Not Specified
Intervention: Device: Vaginal Heat Wash-Out Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00443027
A9001303
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

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