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

Phase 1

Completed

• Conditions: Sexual Dysfunction, Physiological
• Interventions: Device: Vaginal Heat Wash-Out Device

• Registration Number: NCT00443248
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal Heat Wash-Out Device	Vaginal Heat Wash-Out Device	-

Primary Outcome Measures

Name	Time	Method
To assess the safety and toleration of the heat washout device.	2 weeks
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.	2 weeks

Secondary Outcome Measures

Name	Time	Method
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.	2 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 Nedlands, Western Australia, Australia