Pharmacist-Administered Injections for Contraception

Contraception Clinical Trial

— PAD  

Official title:

Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775047
• Other study ID #: 05-EPID-52
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: October 16, 2008
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2008
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• Pharmacist-administered
women will receive their injections at a pharmacy by a clinical pharmacist
• 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.

Locations

Country	Name	City	State
United States	Planned Parenthood of Central North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance in returning for 3 month and 6 month injections		3 months and 6 months after first injection	No
Secondary	Attitudes about clinical setting		3 months and 6 months	No