NCT00443027

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 is 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 changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

March 2, 2007

Last Update Submit

May 23, 2019

Conditions

Sexual Dysfunction, Physiological

Outcome Measures

Primary Outcomes (2)

  • To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

    28d

  • To assess the safety and toleration of the heat washout device.

    28d

Secondary Outcomes (1)

  • To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.

    28d

Study Arms (1)

Vaginal Heat Wash-Out Device

EXPERIMENTAL
Device: Vaginal Heat Wash-Out Device

Interventions

Vaginal Heat Wash-Out DeviceDEVICE

No drug administered. Device tested three times with each subject.

Vaginal Heat Wash-Out Device

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
  • Subjects must be void of Female Sexual Disorder.

You may not qualify if:

  • Pregnant or lactating women
  • Postmenopausal subjects
  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Dulwich, South Australia, 5065, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Related Links

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 5, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

AU(2)