Sayana-Uniject Volumetric Delivery NCT01298479

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

The purpose of this study is to determine the volumetric delivery of the Uniject.

Observe subjects deliver the drug None used

Recruitment information / eligibility
Status	Completed
Enrollment	25
Est. completion date	June 2010
Est. primary completion date	June 2010
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years to 65 Years
Eligibility	Inclusion Criteria: - Nurses Exclusion Criteria: - Non-nurses

Other:
• Uniject
single use container

Locations
Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors *(1)*
Lead Sponsor	Collaborator
Pfizer

Belgium,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system).		Visit 1