Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

Fertility Clinical Trial

— SAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770887
• Other study ID #: 08-2404
• Status: Completed
• Phase: N/A
• First received: October 9, 2008
• Last updated: August 9, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Fertility

Intervention

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

Locations

Country	Name	City	State
United States	Planned Parenthood of Southwest and Central Florida	Fort Myers	Florida
United States	Planned Parenthood of Southwest and Central Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Pfizer, Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Becker WJ, Riess CM, Hoag J. Effectiveness of subcutaneous dihydroergotamine by home injection for migraine. Headache. 1996 Mar;36(3):144-8. — View Citation

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. — View Citation

Lakha F, Henderson C, Glasier A. The acceptability of self-administration of subcutaneous Depo-Provera. Contraception. 2005 Jul;72(1):14-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stanwood NL, Eastwood K, Carletta A. Self-injection of monthly combined hormonal contraceptive. Contraception. 2006 Jan;73(1):53-5. Epub 2005 Nov 14. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with/feasibility of self injection of subcutaneous depot medroxyprogesterone acetate		At onset of trial and every 12 weeks for 1 year	No
Secondary	Continuation rates of depot medroxyprogesterone acetate among self-injectors		Every 12 weeks for 1 year	No