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Pharmacist-Administered Injections for Contraception (PAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775047
First Posted: October 17, 2008
Last Update Posted: October 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
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.

Condition Intervention
Contraception Other: Pharmacist-administered Other: clinic-administered injections

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Compliance in returning for 3 month and 6 month injections [ Time Frame: 3 months and 6 months after first injection ]

Secondary Outcome Measures:
  • Attitudes about clinical setting [ Time Frame: 3 months and 6 months ]

Enrollment: 50
Study Start Date: August 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacy
Women receive their second and third depot-medroxyprogesterone acetate injections at the pharmacy by clinical pharmacists
Other: Pharmacist-administered
women will receive their injections at a pharmacy by a clinical pharmacist
Other Name: SQ Depo-Provera
Active Comparator: Planned Parenthood clinic
Women receive their second and third depot-medroxyprogesterone acetate injections per usual care at their Planned Parenthood clinic.
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775047


Locations
United States, North Carolina
Planned Parenthood of Central North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Pfizer
Investigators
Principal Investigator: Carla Picardo, MD, MPH Dept. of Social Medicine, University of North Carolina
  More Information

Responsible Party: Carla Picardo, MD, MPH, University of North Carolina, Dept. of Social Medicine
ClinicalTrials.gov Identifier: NCT00775047     History of Changes
Other Study ID Numbers: 05-EPID-52
First Submitted: October 15, 2008
First Posted: October 17, 2008
Last Update Posted: October 17, 2008
Last Verified: October 2008

Keywords provided by University of North Carolina, Chapel Hill:
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

Additional relevant MeSH terms:
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents