Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate (SAD)

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

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

Study Overview

• Status: Completed
• Conditions: Fertility
• Intervention / Treatment: Procedure: Self administration

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33919
      • Planned Parenthood of Southwest and Central Florida
    • Tampa, Florida, United States, 33617
      • Planned Parenthood of Southwest and Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Pfizer; Planned Parenthood Federation of America
• Investigators: Principal Investigator: Sujatha Prabhakaran, MD, Planned Parenthood of Southwest and Central Florida

Publications and helpful links

General Publications

• Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. doi: 10.1016/j.jadohealth.2006.10.018.
• Potter LS, Dalberth BT, Canamar R, Betz M. Depot medroxyprogesterone acetate pioneers. A retrospective study at a North Carolina Health Department. Contraception. 1997 Nov;56(5):305-12. doi: 10.1016/s0010-7824(97)00160-1.
• Nelson AL, Katz T. Initiation and continuation rates seen in 2-year experience with Same Day injections of DMPA. Contraception. 2007 Feb;75(2):84-7. doi: 10.1016/j.contraception.2006.09.007. Epub 2006 Oct 31.
• Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007 Oct;76(4):267-72. doi: 10.1016/j.contraception.2007.06.008. Epub 2007 Aug 28.
• Lim SW, Rieder J, Coupey SM, Bijur PE. Depot medroxyprogesterone acetate use in inner-city, minority adolescents: continuation rates and characteristics of long-term users. Arch Pediatr Adolesc Med. 1999 Oct;153(10):1068-72. doi: 10.1001/archpedi.153.10.1068.
• Drug Information. [Internet]. Rockville, MD: United States Food and Drug Administration; CDER Drug and Biologic Approvals for Calendar Year 2004; [cited December 12, 2007]. Available from: http://www.fda.gov/cder/rdmt/ndaaps04cy.htm
• Jain J, Jakimiuk AJ, Bode FR, Ross D, Kaunitz AM. Contraceptive efficacy and safety of DMPA-SC. Contraception. 2004 Oct;70(4):269-75. doi: 10.1016/j.contraception.2004.06.011.
• Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574-82. doi: 10.1046/j.1365-2648.2000.01312.x.
• Watts AC, Howie CR, Simpson AH. Assessment of a self-administration protocol for extended subcutaneous thromboprophylaxis in lower limb arthroplasty. J Bone Joint Surg Br. 2006 Jan;88(1):107-10. doi: 10.1302/0301-620X.88B1.17003.
• Nichols J, Knochenhauer E, Fein SH, Nardi RV, Marshall DC. Subcutaneously administered Repronex in oligoovulatory female patients undergoing ovulation induction is as effective and well tolerated as intramuscular human menopausal gonadotropin treatment. Fertil Steril. 2001 Jul;76(1):58-66. doi: 10.1016/s0015-0282(01)01856-8.
• Becker WJ, Riess CM, Hoag J. Effectiveness of subcutaneous dihydroergotamine by home injection for migraine. Headache. 1996 Mar;36(3):144-8. doi: 10.1046/j.1526-4610.1996.3603144.x.
• Stanwood NL, Eastwood K, Carletta A. Self-injection of monthly combined hormonal contraceptive. Contraception. 2006 Jan;73(1):53-5. doi: 10.1016/j.contraception.2005.05.020. Epub 2005 Nov 14.
• Bahamondes L, Marchi NM, Nakagava HM, de Melo ML, Cristofoletti Mde L, Pellini E, Scozzafave RH, Petta C. Self-administration with UniJect of the once-a-month injectable contraceptive Cyclofem. Contraception. 1997 Nov;56(5):301-4. doi: 10.1016/s0010-7824(97)00162-5.
• Lakha F, Henderson C, Glasier A. The acceptability of self-administration of subcutaneous Depo-Provera. Contraception. 2005 Jul;72(1):14-8. doi: 10.1016/j.contraception.2004.12.002.
• Mosher WD, Martinez GM, Chandra A, Abma JC, Willson SJ. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data. 2004 Dec 10;(350):1-36.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (ESTIMATE): October 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2011
• Last Update Submitted That Met QC Criteria: August 9, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Undesired fertility
• Other Study ID Numbers: 08-2404