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Study of Self or Clinic Administration of DepoProvera

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01019369
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : April 15, 2015
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Family Planning Fellowship
Pfizer
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

Tracking Information
First Submitted Date  ICMJE November 18, 2009
First Posted Date  ICMJE November 25, 2009
Results First Submitted Date  ICMJE December 4, 2014
Results First Posted Date  ICMJE April 15, 2015
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE March 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
Number of Participants Continuing DMPA at 6 Months [ Time Frame: 6 months ]
The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
Increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01019369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Number of Participants Continuing DMPA [ Time Frame: 3, 9, 12 months ]
    The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.
  • Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available [ Time Frame: 6, 12 months ]
    The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
  • Prevalence of Participants With Persistent Skin Changes [ Time Frame: 12 months ]
    The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
  • Scaled Satisfaction Score [ Time Frame: 6, 12 months ]
    This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
  • Average Minutes Spent Getting Ready for and Giving the Injection [ Time Frame: 0-12 months ]
    In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2009)
  • Increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints. [ Time Frame: 3, 9, 12 months ]
  • Self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA [ Time Frame: 6, 12 months ]
  • Self administration of SC DMPA is cost effective as compared to clinic administration of SC DMPA. [ Time Frame: 6, 12 months ]
  • Persistent skin changes (dimpling, induration, or atrophy) occur in less than 5% of women using SC DMPA. [ Time Frame: 12 months ]
  • Age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates. [ Time Frame: 6, 12 months ]
  • Ongoing instructional support is not required for self administration of SC DMPA [ Time Frame: 0-12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Self or Clinic Administration of DepoProvera
Official Title  ICMJE Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
Brief Summary Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.
Detailed Description

Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.

Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.

This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Medroxyprogesterone 17-Acetate
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Other Name: depo-subQ 104
Study Arms  ICMJE
  • Experimental: Self Administration of DMPA
    Self administration of subcutaneous depot medroxyprogesterone acetate
    Intervention: Drug: Medroxyprogesterone 17-Acetate
  • Active Comparator: Clinic administration of DMPA
    Clinic administration (routine care) of DMPA
    Intervention: Drug: Medroxyprogesterone 17-Acetate
Publications * Beasley A, White KO, Cremers S, Westhoff C. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception. 2014 May;89(5):352-6. doi: 10.1016/j.contraception.2014.01.026. Epub 2014 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2009)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age greater than or equal to 18 years
  2. seeking DMPA for contraception
  3. English or Spanish speaking
  4. consistent access to a working telephone
  5. availability for follow up for one year

Exclusion Criteria:

  1. suspected or continuing pregnancy
  2. undiagnosed vaginal bleeding
  3. known or suspected breast cancer
  4. acute liver disease
  5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
  6. desire for pregnancy within one year
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01019369
Other Study ID Numbers  ICMJE AAAD8306
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolyn L. Westhoff, Columbia University
Study Sponsor  ICMJE Carolyn L. Westhoff
Collaborators  ICMJE
  • Family Planning Fellowship
  • Pfizer
Investigators  ICMJE
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
Principal Investigator: Anitra Beasley, MD Columbia University
PRS Account Columbia University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP