Clinical trial NCT01019369: Study of Self or Clinic Administration of DepoProvera
Official title: Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Medroxyprogesterone 17-acetate
Self administration
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Family Planning Fellowship
name: Pfizer
First posted: 2009-11-25
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Continuing DMPA at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Continuing DMPA
timeFrame: 3, 9, 12 months
measure: Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available
timeFrame: 6, 12 months
measure: Prevalence of Participants With Persistent Skin Changes
timeFrame: 12 months
measure: Scaled Satisfaction Score
timeFrame: 6, 12 months
measure: Average Minutes Spent Getting Ready for and Giving the Injection
timeFrame: 0-12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University/New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Carolyn Westhoff, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Anitra Beasley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.