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OpenTrials
Completed

NCT Number: NCT00770887

Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood of Southwest and Central Florida, Fort Myers, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self administration

Procedure

Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).

Primary outcomes

  1. Patient satisfaction with/feasibility of self injection of subcutaneous depot medroxyprogesterone acetate

    Time frame: At onset of trial and every 12 weeks for 1 year

Secondary outcomes

  1. Continuation rates of depot medroxyprogesterone acetate among self-injectors

    Time frame: Every 12 weeks for 1 year

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Pfizer
  • Planned Parenthood Federation of America

Registry information

Official study title

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

Acronym: SAD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2008
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.