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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. Identifier: NCT01019369
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : April 15, 2015
Last Update Posted : May 7, 2019
Family Planning Fellowship
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Medroxyprogesterone 17-Acetate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
Study Start Date : March 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Self Administration of DMPA
Self administration of subcutaneous depot medroxyprogesterone acetate
Drug: Medroxyprogesterone 17-Acetate
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Other Name: depo-subQ 104

Active Comparator: Clinic administration of DMPA
Clinic administration (routine care) of DMPA
Drug: Medroxyprogesterone 17-Acetate
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Other Name: depo-subQ 104

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)

  4. 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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01019369

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United States, New York
Columbia University/New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Carolyn L. Westhoff
Family Planning Fellowship
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Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
Principal Investigator: Anitra Beasley, MD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology, Columbia University Identifier: NCT01019369    
Other Study ID Numbers: AAAD8306
First Posted: November 25, 2009    Key Record Dates
Results First Posted: April 15, 2015
Last Update Posted: May 7, 2019
Last Verified: April 2019
Keywords provided by Carolyn L. Westhoff, Columbia University:
Medroxyprogesterone 17-acetate
Self administration
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents