Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
NCT ID: NCT00770887
Last Updated: 2011-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2010-05-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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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
Self administration
Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).
Interventions
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Self administration
Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Pfizer
INDUSTRY
Planned Parenthood Federation of America
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Planned Parenthood of Southwest and Central Florida
Principal Investigators
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Sujatha Prabhakaran, MD
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood of Southwest and Central Florida
Locations
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Planned Parenthood of Southwest and Central Florida
Fort Myers, Florida, United States
Planned Parenthood of Southwest and Central Florida
Tampa, Florida, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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08-2404
Identifier Type: -
Identifier Source: org_study_id
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