Pharmacist-Administered Injections for Contraception (PAD)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00775047
First received: October 15, 2008
Last updated: October 16, 2008
Last verified: October 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Attitudes about clinical setting [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 15, 2008
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014