Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fertility
Intervention: Self administration (Procedure)
Phase: N/A
Status: Completed
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): Sujatha Prabhakaran, MD, Principal Investigator, Affiliation: Planned Parenthood of Southwest and Central Florida
Summary
The purpose of this study is to assess continuation rates and patient satisfaction with self
administration subcutaneous depot medroxyprogesterone acetate.
Clinical Details
Official title: Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate: A Pilot Observational Study of Feasibility and Acceptability
Study design: Time Perspective: Prospective
Primary outcome: Patient satisfaction with/feasibility of self injection of subcutaneous depot medroxyprogesterone acetate
Secondary outcome: Continuation rates of depot medroxyprogesterone acetate among self-injectors
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Planned Parenthood of Southwest and Central Florida, Fort Myers, Florida 33919, United States
Planned Parenthood of Southwest and Central Florida, Tampa, Florida 33617, United States
Additional Information
Related publications: Potter LS, Dalberth BT, Cañamar R, Betz M. Depot medroxyprogesterone acetate pioneers. A retrospective study at a North Carolina Health Department. Contraception. 1997 Nov;56(5):305-12. 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. Epub 2006 Oct 31. Rickert VI, Tiezzi L, Lipshutz J, León J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007 Oct;76(4):267-72. 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. 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. Rodger MA, King L. Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574-82. Review. 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. 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. Becker WJ, Riess CM, Hoag J. Effectiveness of subcutaneous dihydroergotamine by home injection for migraine. Headache. 1996 Mar;36(3):144-8. Stanwood NL, Eastwood K, Carletta A. Self-injection of monthly combined hormonal contraceptive. Contraception. 2006 Jan;73(1):53-5. 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. Lakha F, Henderson C, Glasier A. The acceptability of self-administration of subcutaneous Depo-Provera. Contraception. 2005 Jul;72(1):14-8. 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.
Starting date: May 2010
Last updated: August 9, 2011
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