Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

NCT00770887 | Completed

• 1 other identifier: 08-2404
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Fertility

Keywords

Undesired fertility

Outcome Measures

Primary Outcomes (1)

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

  At onset of trial and every 12 weeks for 1 year

Secondary Outcomes (1)

• Continuation rates of depot medroxyprogesterone acetate among self-injectors

  Every 12 weeks for 1 year

Study Arms (1)

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

Interventions

Self administration PROCEDURE

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

Study participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Pfizer: collaborator
• Planned Parenthood Federation of America: collaborator

Study Sites (2)

Planned Parenthood of Southwest and Central Florida

Fort Myers, Florida, 33919, United States

Location

Planned Parenthood of Southwest and Central Florida

Tampa, Florida, 33617, United States

Location

Related Publications (15)

• 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.

  PMID: 9437559 BACKGROUND

• 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.

  PMID: 17241834 BACKGROUND

• 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.

  PMID: 17185202 BACKGROUND

• 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.

  PMID: 17900435 BACKGROUND

• 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.

  PMID: 10520615 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15451329 BACKGROUND

• 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.

  PMID: 10718876 BACKGROUND

• 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.

  PMID: 16365131 BACKGROUND

• 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.

  PMID: 11438320 BACKGROUND

• 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.

  PMID: 8984085 BACKGROUND

• 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.

  PMID: 16371295 BACKGROUND

• 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.

  PMID: 9437558 BACKGROUND

• 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.

  PMID: 15964286 BACKGROUND

• 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.

  PMID: 15633582 BACKGROUND

MeSH Terms

Interventions

Self Administration

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Self Care

Study Officials

• Sujatha Prabhakaran, MD

  Planned Parenthood of Southwest and Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

US (2)