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Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate (SAD)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Planned Parenthood Federation of America
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00770887
First received: October 9, 2008
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Fertility
 Procedure: Self administration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate: A Pilot Observational Study of Feasibility and Acceptability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continuation rates of depot medroxyprogesterone acetate among self-injectors [ Time Frame: Every 12 weeks for 1 year ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study participants
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
Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770887

Locations
United States, Florida
Planned Parenthood of Southwest and Central Florida
Fort Myers, Florida, United States, 33919
Planned Parenthood of Southwest and Central Florida
Tampa, Florida, United States, 33617
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Pfizer
Planned Parenthood Federation of America
Investigators
Principal Investigator: Sujatha Prabhakaran, MD Planned Parenthood of Southwest and Central Florida
  More Information

Publications:

Responsible Party: Sujatha Prabhakaran MD, MPH Medical Director, Planned Parenthood of Southwest and Central Florida
ClinicalTrials.gov Identifier: NCT00770887     History of Changes
Other Study ID Numbers: 08-2404
Study First Received: October 9, 2008
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Undesired fertility

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 June 18, 2013