SAD: Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
Study Details
Study Description
Brief Summary
The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- 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
- Continuation rates of depot medroxyprogesterone acetate among self-injectors [Every 12 weeks for 1 year]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Planned Parenthood of Southwest and Central Florida | Fort Myers | Florida | United States | 33919 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Becker WJ, Riess CM, Hoag J. Effectiveness of subcutaneous dihydroergotamine by home injection for migraine. Headache. 1996 Mar;36(3):144-8.
- 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.
- Lakha F, Henderson C, Glasier A. The acceptability of self-administration of subcutaneous Depo-Provera. Contraception. 2005 Jul;72(1):14-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stanwood NL, Eastwood K, Carletta A. Self-injection of monthly combined hormonal contraceptive. Contraception. 2006 Jan;73(1):53-5. Epub 2005 Nov 14.
- 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.
- 08-2404