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UK-369, 003

Phase 2

Impotence | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Mar 23, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

UK-369, 003 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT00479505Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive BladderUrinary Bladder, Overactive
COMPLETED275 Analytics
NCT00141349Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile DysfunctionImpotence
COMPLETED300 Analytics
PHASE2COMPLETED
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
Urinary Bladder, OveractiveUnlock trial analytics
PHASE2COMPLETED
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
ImpotenceUnlock trial analytics

Study Endpoints

Primary Endpoints

This is an estimation study with no primary endpoint. There are efficacy endpoints.
12 Weeks
The time needed to obtain an erection hard enough to attempt sexual intercourse.
Effect on exercise tolerance

Secondary Endpoints

Patient reported treatment impact questionnaire.
12 Weeks
Lower urinary tract symptoms diary.
12 Weeks
International prostate symptom score questionnaire.
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
UK-369,003DRUGUK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Male subjects aged 18 years and above * documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours. Exclusion Criteria: * Neurological diseases known to affect bladder function. * U...

Countries:AustraliaCanadaChileColombiaFinlandFranceGermanyGreeceItalyLatviaNorwayPolandSlovakiaSpainSwitzerlandUnited KingdomUnited StatesArgentinaIndia
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Frequently asked questions about UK-369, 003

What is UK-369,003 used for?

UK-369,003 is an investigational small molecule being studied for male urogenital and pulmonary conditions, including erectile dysfunction (impotence), chronic obstructive pulmonary disease, benign prostatic hyperplasia, and overactive bladder. It is not approved and remains in clinical development.

Who makes UK-369,003?

UK-369,003 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug across multiple countries.

What phase is UK-369,003 in?

UK-369,003 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, along with a Phase 1 drug interaction study.

What clinical trials is UK-369,003 in?

UK-369,003 has been studied in several completed trials, including NCT00141349 in male erectile dysfunction, NCT00408954 in men with lower urinary tract symptoms, NCT00479505 in overactive bladder, and NCT00814736, a Phase 1 study with sildenafil.

Is UK-369,003 the same as sildenafil?

No, UK-369,003 is a distinct investigational compound. A completed Phase 1 trial (NCT00814736) studied the safety and toleration of single-dose sildenafil in subjects receiving chronic UK-369,003, indicating they are separate drugs that may be used together.