Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

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

Detailed Description
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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.

Official Title
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Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate: A Pilot Observational Study of Feasibility and Acceptability

Conditions
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Fertility

Intervention / Treatment
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* Procedure: Self administration


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study participants<br>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 | Procedure: Self administration<br>* Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation rates of depot medroxyprogesterone acetate among self-injectors |  | Every 12 weeks for 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Undesired fertility