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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Sexual Dysfunction, Physiological

Treatments

Device: Vaginal Heat Wash-Out Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00443248

A9001302

Details and patient eligibility

About

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).

Full description

Medical Device Development

Enrollment

64 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.