Pharmacist-Administered Injections for Contraception

NCT00775047

Last updated date
Study Location
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, 27514, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacist-Administered Injections for Contraception
Official Title  ICMJE Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Other: Pharmacist-administered
    women will receive their injections at a pharmacy by a clinical pharmacist
    Other Name: SQ Depo-Provera
  • 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.
    Other Name: SQ Depo-Provera
Study Arms  ICMJE
  • Experimental: Pharmacy
    Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists
    Intervention: Other: Pharmacist-administered
  • Active Comparator: Planned Parenthood clinic
    Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic.
    Intervention: Other: clinic-administered injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775047
Other Study ID Numbers  ICMJE 05-EPID-52
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carla Picardo, MD, MPH, University of North Carolina, Dept. of Social Medicine
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Carla Picardo, MD, MPHDept. of Social Medicine, University of North Carolina
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP