Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

Completed

• Conditions: Fertility
• Interventions: Procedure: Self administration

• Registration Number: NCT00770887
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.

Detailed Description

This observational study will include new or current Depo Provera users who express interest in attempting subcutaneous self administration of depot medroxyprogesterone acetate. Candidates will be taught self administration by a clinic assistant at Planned Parenthood of Southwest and Central Florida. Patients who are able to correctly self administer the medication and wish to attempt to continue home self administration, will be provided the supplies and educational materials to do so. Continuation rates and satisfaction with this method will be assessed using preaddressed surveys that patients will return with the above information.

Study Timeline

• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Study Start: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women 18 years or older
• Can understand written and spoken English
• Current or past user of DMPA or desires initiation of DMPA for contraception
• Provider has approved DMPA use in this woman
• Willing to consider/attempt DMPA self-injection.
• Willing to receive phone calls/letter for follow up
• Willing to return letters for follow up

Read More

Exclusion Criteria

Has contraindications to DMPA use:

• Vaginal bleeding of unknown etiology
• Medication use for Cushing's syndrome
• Currently pregnant
• Blood pressure >160/100
• Intolerance to the idea of irregular or absent menses

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study participants	Self administration	This study will enroll 50 English-speaking/literate women at least 18 years of age of any race who have sought contraception with DMPA at the Planned Parenthood of Southwest and Central Florida clinics in Tampa and Fort Myers. Patients who choose to begin DMPA or who have already been using DMPA will be approached regarding voluntary participation in the study. Because DMPA is contraindicated in pregnancy, women with a positive urine pregnancy will not be eligible. Should a woman become pregnant during the study, she will receive no further DMPA injections

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with/feasibility of self injection of subcutaneous depot medroxyprogesterone acetate	At onset of trial and every 12 weeks for 1 year

Secondary Outcome Measures

Name	Time	Method
Continuation rates of depot medroxyprogesterone acetate among self-injectors	Every 12 weeks for 1 year

Trial Locations

Locations (1)

Planned Parenthood of Southwest and Central Florida; 🇺🇸 Tampa, Florida, United States