Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- an... | NCT00443248

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

NCT00443248

Sponsor

Pfizer

Status

Completed

Last Update Posted

May 28, 2019Actual

Enrollment

64Estimated

Phase

Phase 1

Conditions

Sexual Dysfunction, Physiological

Interventions

Vaginal Heat Wash-Out Device

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2019

Last Update Posted Date

May 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal Heat Wash-Out Device	Experimental		Device: Vaginal Heat Wash-Out Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal Heat Wash-Out Device	Device	No drug administered. Device tested twice with each subject.	Vaginal Heat Wash-Out Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Dulwich	South Australia	5065	Australia
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases