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Pharmacist-Administered Injections for Contraception

NCT ID: NCT00775047

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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

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Contraception

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pharmacy

Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists

Group Type EXPERIMENTAL

Pharmacist-administered

Intervention Type OTHER

women will receive their injections at a pharmacy by a clinical pharmacist

Planned Parenthood clinic

Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic.

Group Type ACTIVE_COMPARATOR

clinic-administered injections

Intervention Type OTHER

women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.

Interventions

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Pharmacist-administered

women will receive their injections at a pharmacy by a clinical pharmacist

Intervention Type OTHER

clinic-administered injections

women will return for their injections to the clinic where recruitment took place. They will receive one at 3 months and 6 months.

Intervention Type OTHER

Other Intervention Names

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SQ Depo-Provera SQ Depo-Provera

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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University of North Carolina, Dept. of Social Medicine

Principal Investigators

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Carla Picardo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dept. of Social Medicine, University of North Carolina

Locations

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Planned Parenthood of Central North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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05-EPID-52

Identifier Type: -

Identifier Source: org_study_id