Recent Updates
Recently added Catalysts

Vaginal Heat Wash-Out Device

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00443027Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.PHASE1 COMPLETED 12 — — Mar 1, 2007Oct 1, 2008May 28, 20192 Australia
NCT00443248Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).PHASE1 COMPLETED 64 — — Mar 1, 2007Oct 1, 2008May 28, 20192 Australia
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria