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Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.

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NCT00443027

Last updated on May 10, 2018
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Study Location
Pfizer Investigational Site
Dulwich, South Australia, 5065 Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Physiological Sexual Dysfunction
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.

- Subjects must be void of Female Sexual Disorder.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00443027
Pfizer
Completed
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.

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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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00443027
A9001303
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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