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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00443248




Registration number
NCT00443248
Ethics application status
Date submitted
2/03/2007
Date registered
5/03/2007
Date last updated
28/05/2019

Titles & IDs
Public title
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Scientific 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.
Secondary ID [1] 0 0
A9001302
Universal Trial Number (UTN)
Trial acronym
FSAD HWO VBF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction, Physiological 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Vaginal Heat Wash-Out Device

Experimental: Vaginal Heat Wash-Out Device -


Treatment: Devices: Vaginal Heat Wash-Out Device
No drug administered. Device tested twice with each subject.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and toleration of the heat washout device.
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
Timepoint [2] 0 0
2 weeks
Secondary outcome [1] 0 0
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
Timepoint [1] 0 0
2 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Dulwich
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
5065 - Dulwich
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00443248
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00443248