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FertilitySADNCT00770887

Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

An observational study of Fertility, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fertility
What is being tested?
Self administration
How many people
50 participants
Where
2 sitesUnited States
Study dates
May 2010to Jun 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Planned Parenthood of Southwest and Central Florida

    Fort Myers, Florida, 33919

  • Planned Parenthood of Southwest and Central Florida

    Tampa, Florida, 33617

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Fertility
Being tested
Self administration
Keywords
Undesired fertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self administrationProcedure or surgery

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

Study groups in NCT00770887
Study groupRoleWhat they receive
Study participantsThis 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
Receives: Procedure: Self administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At onset of trial and every 12 weeks for 1 year

Secondary outcomes (1)

  1. Continuation rates of depot medroxyprogesterone acetate among self-injectors

    Measured: Every 12 weeks for 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2008 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770887
Sponsor's protocol ID
08-2404
Acronym
SAD
Status last verified
Aug 2011
First submitted
9 Oct 2008
Last updated
11 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9437559

  • 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.

    PubMed 17241834

  • 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.

    PubMed 17185202

  • 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.

    PubMed 17900435

  • 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.

    PubMed 10520615

  • 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.

    PubMed 15451329

  • 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.

    PubMed 10718876

  • 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.

    PubMed 16365131

  • 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.

    PubMed 11438320

  • 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.

    PubMed 8984085

  • 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.

    PubMed 16371295

  • 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.

    PubMed 9437558

  • 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.

    PubMed 15964286

  • 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.

    PubMed 15633582

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction with/feasibility of self injection of subcutaneous depot medroxyprogesterone acetate (time frame: At onset of trial and every 12 weeks for 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770887, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.

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