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Vaginal Heat Wash-Out Device

Phase 1

Sexual Dysfunction, Physiological | Unknown | Other |Pfizer, Inc.|Last Updated: May 28, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Vaginal Heat Wash-Out Device · 2 trials · 1 indication

Phase 1 2
NCT00443027Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.Sexual Dysfunction, Physiological
COMPLETED12 Analytics
NCT00443248Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).Sexual Dysfunction, Physiological
COMPLETED64 Analytics
PHASE1COMPLETED
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Sexual Dysfunction, Physiological
NCT0044302712
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PHASE1COMPLETED
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Sexual Dysfunction, Physiological
NCT0044324864
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Study Endpoints

Primary Endpoints

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
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
2 weeks

Secondary Endpoints

To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.
28d
To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.
2 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Vaginal Heat Wash-Out DeviceEXPERIMENTAL -

Interventions

NameTypeDescription
Vaginal Heat Wash-Out DeviceDEVICENo drug administered. Device tested three times with each subject.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles. * Subjects must be void of Female Sexual Disorder. Exclusion Criteria: * Pregnant or lactating women * Postmenopausal subjects * Subjects with evidence or history of clinically significant hemato...

Countries:Australia
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Frequently asked questions about Vaginal Heat Wash-Out Device

What is the Vaginal Heat Wash-Out Device used for?

The Vaginal Heat Wash-Out Device is an investigational device being studied for sexual dysfunction, physiological, in women. It is in Phase 1 clinical development and is not yet approved. Two early-stage trials have been completed to evaluate its effects on vaginal blood flow and its use in pre- and postmenopausal women with and without female sexual arousal disorder.

Who makes the Vaginal Heat Wash-Out Device?

Pfizer, Inc. (NYSE: PFE) is developing the Vaginal Heat Wash-Out Device. The company is conducting Phase 1 clinical trials to evaluate the device in women with physiological sexual dysfunction. The device is still in early-stage clinical development and is not yet approved for commercial use.

What phase is the Vaginal Heat Wash-Out Device in?

The Vaginal Heat Wash-Out Device is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 76 participants enrolled. The device is investigational and has not received regulatory approval. It is being studied for physiological sexual dysfunction in women.

What clinical trials is the Vaginal Heat Wash-Out Device in?

The Vaginal Heat Wash-Out Device has been studied in two completed Phase 1 trials: NCT00443027, which examined the effect of the menstrual cycle on vaginal blood flow in pre-menopausal healthy women, and NCT00443248, which evaluated the device in pre- and postmenopausal women with and without female sexual arousal disorder. Both trials were conducted in Australia.

Is the Vaginal Heat Wash-Out Device FDA approved?

The Vaginal Heat Wash-Out Device is not FDA approved. It is an investigational device currently in Phase 1 clinical development. Two early-stage trials have been completed, but the device has not yet been evaluated in later-phase studies or submitted for regulatory approval. It remains under investigation for physiological sexual dysfunction.