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delivery system

Phase 3

Erectile Dysfunction | Unknown | Endocrine |Pfizer, Inc.|Last Updated: Apr 6, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

delivery system · 1 trial · 1 indication

Phase 3 1
NCT01008605Caverject User StudyErectile Dysfunction
COMPLETED48 Analytics
PHASE3COMPLETED
Caverject User Study
Erectile DysfunctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
Day 1

Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.

Secondary Endpoints

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Day 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Caverject ImpulseEXPERIMENTALrepresentative users

Interventions

NameTypeDescription
delivery systemOTHERsyringe
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Eligibility Criteria

Age Range40 Years to 70 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Age 40 to 70 Exclusion Criteria: Prior syringe skills

Countries:United States
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Frequently asked questions about delivery system

What is Caverject used for?

Caverject is used for the treatment of Erectile Dysfunction. It is an investigational drug being developed by Pfizer, Inc. and is currently in Phase 3 clinical development. The drug has been studied in a completed clinical trial in the United States.

Who makes Caverject?

Caverject is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for the treatment of Erectile Dysfunction.

What phase is Caverject in?

Caverject is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Erectile Dysfunction, with one completed Phase 3 trial.

What clinical trials is Caverject in?

Caverject has been studied in one clinical trial with the identifier NCT01008605, titled 'Caverject User Study'. This was a Phase 3 trial that has been completed, enrolling 48 participants in the United States. The trial was uncontrolled and not randomized or double-blind.

Is Caverject the same as delivery system?

Caverject is also known as delivery system. This alternative name may be used in some contexts, but the drug is primarily referred to as Caverject in clinical development. It is being developed by Pfizer, Inc. for the treatment of Erectile Dysfunction.