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

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

Tracking Information

• First Submitted Date: March 2, 2007
• First Posted Date: March 5, 2007
• Last Update Posted Date: May 28, 2019
• Study Start Date: March 2007
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures (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 (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: Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
• 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.
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Sexual Dysfunction, Physiological

Intervention

Device: Vaginal Heat Wash-Out Device

No drug administered. Device tested twice with each subject.

Study Arms

Experimental: Vaginal Heat Wash-Out Device

Intervention: Device: Vaginal Heat Wash-Out Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: March 2, 2007): 64
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00443248
• Other Study ID Numbers: A9001302
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2019