Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).

Sexual Dysfunction, Physiological Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443248
• Other study ID #: A9001302
• Status: Completed
• Phase: Phase 1
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Medical Device Development

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Device:
• Vaginal Heat Wash-Out Device
No drug administered. Device tested twice with each subject.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Dulwich	South Australia
Australia	Pfizer Investigational Site	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and toleration of the heat washout device.		2 weeks
Primary	To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.		2 weeks
Secondary	To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.		2 weeks

External Links

•   To obtain contact information for a study center near you, click here.