ContraceptionPhase 4QuickstartNCT01902485
Study of Immediate Start of Progestin Contraceptives in Medical Abortion
A Phase 4 study testing Timing of Contraceptive Initiation in Medical Abortion in people with Contraception, run by Gynuity Health Projects at 8 sites in 2 countries.
Trial summary
This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Timing of Contraceptive Initiation in Medical Abortion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 937 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women having medical abortion desiring progestin-based contraceptives (injectables or implants)
Who cannot join
None listed.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Bayview Medical Center
Baltimore, Maryland
Boston Medical Center
Boston, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts
Planned Parenthood of the Pacific Southwest
Chula Vista, California
Planned Parenthood Northern California
Eureka, California
Planned Parenthood of Southern New England
Stamford, Connecticut
Mexico2 sites
Centro de Salud Beatriz Velasco de Aleman
Mexico City
Centro de Salud Santa Catarina
Mexico City
About this study
Official title: Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial
This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.
- Conditions
- Contraception
- Being tested
- Timing of Contraceptive Initiation in Medical Abortion
- Keywords
- Contraception, Medical Abortion, Implant, Injectable, Quickstart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of Contraceptive Initiation in Medical AbortionOther
| Study group | Role | What they receive |
|---|---|---|
| Quickstart | Active comparator | Immediate start Receives: Other: Timing of Contraceptive Initiation in Medical Abortion |
| Afterstart | Active comparator | Delayed start Receives: Other: Timing of Contraceptive Initiation in Medical Abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Abortion Failure
Measured: One month after enrollment
Repeat Pregnancy
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902485
- Sponsor's protocol ID
- 1009
- Acronym
- Quickstart
- Status last verified
- Mar 2016
- First submitted
- 15 Jul 2013
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raymond EG, Weaver MA, Louie KS, Tan YL, Bousieguez M, Arangure-Peraza AG, Lugo-Hernandez EM, Sanhueza P, Goldberg AB, Culwell KR, Kaplan C, Memmel L, Sonalkar S, Jamshidi R, Winikoff B. Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):739-45. doi: 10.1097/AOG.0000000000001627.
PubMed 27607859Raymond EG, Weaver MA, Tan YL, Louie KS, Bousieguez M, Lugo-Hernandez EM, Arangure-Peraza AG, Sanhueza P, Kaplan C, Sonalkar S, Goldberg AB, Culwell KR, Memmel L, Jamshidi R, Winikoff B. Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):306-12. doi: 10.1097/AOG.0000000000001274.
PubMed 26942358
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Initiation of Progestin Contraceptives in First Trimester Medical Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01902485
- Acronym / sponsor ID
- Quickstart / 1009
- Conditions
- Contraception
- Keywords
- Contraception, Medical Abortion, Implant, Injectable, Quickstart
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 937 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare immediate to post-abortion start of two progestin-based contraceptives (DMPA and etonorgestrel implants) among women having first trimester medical abortion who wish to use that method for post-abortion contraception.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quickstart | Active comparator | Other: Timing of Contraceptive Initiation in Medical AbortionImmediate start |
| Afterstart | Active comparator | Other: Timing of Contraceptive Initiation in Medical AbortionDelayed start |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women having medical abortion desiring progestin-based contraceptives (injectables or implants)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Timing of Contraceptive Initiation in Medical Abortion | Other | Afterstart, Quickstart |
Primary outcome
Medical Abortion Failure
Time frame: One month after enrollment
Repeat Pregnancy
Time frame: 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Derived from this study: PubMed 27607859Raymond EG, Weaver MA, Louie KS, Tan YL, Bousieguez M, Arangure-Peraza AG, Lugo-Hernandez EM, Sanhueza P, Goldberg AB, Culwell KR, Kaplan C, Memmel L, Sonalkar S, Jamshidi R, Winikoff B. Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):739-45. doi: 10.1097/AOG.0000000000001627.
- Derived from this study: PubMed 26942358Raymond EG, Weaver MA, Tan YL, Louie KS, Bousieguez M, Lugo-Hernandez EM, Arangure-Peraza AG, Sanhueza P, Kaplan C, Sonalkar S, Goldberg AB, Culwell KR, Memmel L, Jamshidi R, Winikoff B. Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):306-12. doi: 10.1097/AOG.0000000000001274.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timing of Contraceptive Initiation in Medical Abortion in people with Contraception, run by Gynuity Health Projects at 8 sites in 2 countries.
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 1 inclusion and 0 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medical Abortion Failure (time frame: One month after enrollment). The study lists 2 primary outcomes in all. 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 NCT01902485, which also lists 2 linked publications.
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 4 Mar 2016.