Study of Self or Clinic Administration of DepoProvera

This study has been completed.
Sponsor:
Collaborators:
Family Planning Fellowship
Pfizer
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT01019369
First received: November 18, 2009
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Contraception
Drug: Medroxyprogesterone 17-Acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • Self administration of SC DMPA is cost effective as compared to clinic administration of SC DMPA. [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • Persistent skin changes (dimpling, induration, or atrophy) occur in less than 5% of women using SC DMPA. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates. [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
  • Ongoing instructional support is not required for self administration of SC DMPA [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019369

Locations
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
Pfizer
Investigators
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
Principal Investigator: Anitra Beasley, MD Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01019369     History of Changes
Other Study ID Numbers: AAAD8306
Study First Received: November 18, 2009
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Contraception
Medroxyprogesterone 17-acetate
Self administration

Additional relevant MeSH terms:
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014