Pharmacist-Administered Injections for Contraception | NCT00775047

Studies
Pharmacist-Administered Injections for Contraception

NCT00775047

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Oct 17, 2008Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Contraception

Interventions

Pharmacist-administered
clinic-administered injections

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Jul 2008Actual

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see if it is a feasible arrangement to have women receive their second and third birth control injection (with Depo-Provera) at a pharmacy compared with receiving it a Planned Parenthood Clinic. Compliance with returning for injections as well as patient satisfaction with the method, providers, and location where injection was received will be assessed and compared between the two sites. The hypothesis is that there will be no difference in return rates for injections at either the pharmacy or the clinic site.

Detailed Description

Women who want to use or are currently using Depo-Provera for contraception will be randomized to receive their next two injections either back at the Planned Parenthood clinic or at a local pharmacy where pharmacists are trained to give injections. After each injection, women will be asked to complete a questionnaire to assess their attitudes about the method of birth control, their providers, and the location where they received the injection.

Conditions Module

Conditions

Contraception

Keywords

depo medroxyprogesterone acetate
Depo Provera
contraceptive compliance
pharmacists
Compliance in receiving additional Depo Provera injections
Satisfaction in receiving Depo Provera injections at a pharmacy compared with usual clinic

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmacy	Experimental	Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists	Other: Pharmacist-administered
Planned Parenthood clinic	Active Comparator	Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic.	Other: clinic-administered injections

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacist-administered	Other	women will receive their injections at a pharmacy by a clinical pharmacist	Pharmacy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compliance in returning for 3 month and 6 month injections		3 months and 6 months after first injection

Secondary Outcomes

Measure	Description	Time Frame
Attitudes about clinical setting		3 months and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 y.o., English speaking/reading, presenting to Planned Parenthood to use Depo Provera (restarting, first use, or continuing use)

Exclusion Criteria:

Under 18 years of age, English illiterate (reading and verbal)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carla Picardo, MD, MPH	Dept. of Social Medicine, University of North Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood of Central North Carolina		Chapel Hill	North Carolina	27514	United States