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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00443248
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Arm: 1
• Duration (Months): 19.1
• Patients Per Site: 32
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction, Physiological	Device: Vaginal Heat Wash-Out Device	Phase 1

Detailed Description

Medical Device Development

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal Heat Wash-Out Device	Device: Vaginal Heat Wash-Out Device; No drug administered. Device tested twice with each subject.

Outcome Measures

Primary Outcome Measures

1. To assess the safety and toleration of the heat washout device. [2 weeks]

2. To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD. [2 weeks]

Secondary Outcome Measures

1. To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD. [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Dulwich	South Australia	Australia	5065
2	Pfizer Investigational Site	Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00443248
• Other Study ID Numbers: A9001302
• First Posted: Mar 5, 2007
• Last Update Posted: May 28, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Study Results

No Results Posted as of May 28, 2019