ContraceptionNCT01019369
Study of Self or Clinic Administration of DepoProvera
A study testing Medroxyprogesterone 17-Acetate in people with Contraception, run by Carolyn L. Westhoff at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Medroxyprogesterone 17-Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York Presbyterian Hospital
New York, New York, 10032
About this study
Official title: Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Medroxyprogesterone 17-Acetate
- Keywords
- Contraception, Medroxyprogesterone 17-acetate, Self administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone 17-AcetateDrug
Also called depo-subQ 104
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Medroxyprogesterone 17-AcetateDrug
Also called depo-subQ 104
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Self Administration of DMPA | Experimental | Self administration of subcutaneous depot medroxyprogesterone acetate Receives: Drug: Medroxyprogesterone 17-Acetate |
| Clinic administration of DMPA | Active comparator | Clinic administration (routine care) of DMPA Receives: Drug: Medroxyprogesterone 17-Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Continuing DMPA at 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
Measured: 6 months
Secondary outcomes (5)
Number of Participants Continuing DMPA
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.
Measured: 3, 9, 12 months
Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available
The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
Measured: 6, 12 months
Prevalence of Participants With Persistent Skin Changes
The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
Measured: 12 months
Scaled Satisfaction Score
This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
Measured: 6, 12 months
Average Minutes Spent Getting Ready for and Giving the Injection
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.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolyn L. Westhoff
- Sponsor type
- University, hospital or other
- Collaborators
- Family Planning Fellowship, Pfizer
- Responsible party
- Sponsor-investigator, Carolyn L. Westhoff, Columbia University
- Investigators
- Carolyn Westhoff, MD, MSc, Principal investigator, Columbia UniversityAnitra Beasley, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019369
- Sponsor's protocol ID
- AAAD8306
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2009
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 24656555
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
- ClinicalTrials.gov ID
- NCT01019369
- Acronym / sponsor ID
- AAAD8306
- Conditions
- Contraception
- Keywords
- Contraception, Medroxyprogesterone 17-acetate, Self administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Carolyn L. WesthoffUniversity, hospital or other
- Collaborators
- Family Planning Fellowship, Pfizer
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 15 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Administration of DMPA | Experimental | Drug: Medroxyprogesterone 17-AcetateSelf administration of subcutaneous depot medroxyprogesterone acetate |
| Clinic administration of DMPA | Active comparator | Drug: Medroxyprogesterone 17-AcetateClinic administration (routine care) of DMPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medroxyprogesterone 17-AcetateAlso: depo-subQ 104Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year | Drug | Self Administration of DMPA |
| Medroxyprogesterone 17-AcetateAlso: depo-subQ 104Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year | Drug | Clinic administration of DMPA |
Primary outcome
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
5 secondary outcomes
Number of Participants Continuing DMPA
Time frame: 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
Prevalence of Participants With Persistent Skin Changes
Time frame: 12 months
Scaled Satisfaction Score
Time frame: 6, 12 months
Average Minutes Spent Getting Ready for and Giving the Injection
Time frame: 0-12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24656555Beasley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Westhoff, MD, MSc principal investigator
Columbia University
Anitra Beasley, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medroxyprogesterone 17-Acetate in people with Contraception, run by Carolyn L. Westhoff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Continuing DMPA at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01019369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.