Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate

NCT00770887

Last updated date
Study Location
Planned Parenthood of Southwest and Central Florida
Fort Myers, Florida, 33919, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fertility
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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FertilitySelf Administration of Subcutaneous Depot Medroxyprogesterone Acetate
NCT00770887
  1. Fort Myers, Florida
  2. Tampa, Florida
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
Official Title Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate: A Pilot Observational Study of Feasibility and Acceptability
Brief Summary The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition 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).
Study Groups/Cohorts 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
Intervention: Procedure: Self administration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2008)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00770887
Other Study ID Numbers 08-2404
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sujatha Prabhakaran MD, MPH Medical Director, Planned Parenthood of Southwest and Central Florida
Study Sponsor University of North Carolina, Chapel Hill
Collaborators
  • Pfizer
  • Planned Parenthood Federation of America
Investigators
Principal Investigator:Sujatha Prabhakaran, MDPlanned Parenthood of Southwest and Central Florida
PRS Account University of North Carolina, Chapel Hill
Verification Date August 2011