- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019369
Study of Self or Clinic Administration of DepoProvera
Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University/New York Presbyterian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age greater than or equal to 18 years
- seeking DMPA for contraception
- English or Spanish speaking
- consistent access to a working telephone
- availability for follow up for one year
Exclusion Criteria:
- suspected or continuing pregnancy
- undiagnosed vaginal bleeding
- known or suspected breast cancer
- acute liver disease
- known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
- desire for pregnancy within one year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Self Administration of DMPA
Self administration of subcutaneous depot medroxyprogesterone acetate
|
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Other Names:
|
ACTIVE_COMPARATOR: Clinic administration of DMPA
Clinic administration (routine care) of DMPA
|
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3, 9, 12 months
|
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
|
6, 12 months
|
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)
|
12 months
|
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.
|
6, 12 months
|
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.
|
0-12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anitra Beasley, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Medroxyprogesterone Acetate
- Medroxyprogesterone
Other Study ID Numbers
- AAAD8306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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