Early Pregnancy TerminationPhase 4NCT01920022
Quickstart of Nexplanon® at Medical Abortion
A Phase 4 study testing Mifepristone and etonorgestrel in people with Early Pregnancy Termination and Medical Abortion, run by Karolinska Institutet at 7 sites in 2 countries.
Trial summary
Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Early Pregnancy Termination, Medical Abortion, Postabortion Contraception
- What is being tested?
- Mifepristone and etonorgestrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2013to Oct 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women opting for medical abortion and post abortion Nexplanon
- no contraindicated to medical abortion or Nexplanon (according to the SMPc) gestational length up to and including 63 days (determined with ultrasonography)
- able and willing to provide informed consent
Who cannot join
- unwilling to participate,
- unable to communicate in Swedish and English and
- minors (i.e. women < 18 years of age),
- contraindications to Nexplanon®
- women with pathological pregnancies
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden6 sites
Sahlgrenska Universitetssjukhuset/Östra
Gothenburg
Universitetssjukhuset
Linköping
Universitetssjukhuset i Örebro
Örebro
Karolinska Universitetssjukhuset
Stockholm, 17176
Danderyds Hospital
Stockholm
Södersjukhuset
Stockholm
United Kingdom1 site
Chalmers Sexual and Reproductive Health Service
Edinburgh, EH3 9ES
About this study
Official title: Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.
- Being tested
- Mifepristone, etonorgestrel
- Keywords
- medical abortion, postabortion contraception, LARC, Nexplanon, subdermal contraceptive implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Day one of medical abortion
etonorgestrelDrug
Also called Nexplanon, Contraceptive implant
| Study group | Role | What they receive |
|---|---|---|
| Etonorgestrel and mifepristone | Experimental | Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion Receives: Drug: Mifepristone; Drug: etonorgestrel |
| mifepristone | Active comparator | Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortions without surgical intervention
Efficacy of the medical abortion treatment
Measured: at 3 weeks follow up
Secondary outcomes (4)
Unplanned pregnancy
Numbers of pregnancies within the first year following the index abortion
Measured: during one year FU
Number of women with complications
reports and rates of AE/SAE
Measured: evaluated at the 3weeks FU
Rate of implant insertion
Compliance, contraceptive usage
Measured: up to 1year FU
Bleeding
Bleeding will be evaluated with regard to both bleeding during the medical abortion and bleeding patterns during the one year FU
Measured: Evaluated at 1 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Pregnancy TerminationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell-Danielsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920022
- Sponsor's protocol ID
- QW2013
- Status last verified
- Feb 2016
- First submitted
- 6 Aug 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, Aronsson A, Lindh I, Benson L, Gemzell-Danielsson K. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial. Hum Reprod. 2016 Nov;31(11):2484-2490. doi: 10.1093/humrep/dew238. Epub 2016 Sep 22.
PubMed 27664217
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
- ClinicalTrials.gov ID
- NCT01920022
- Acronym / sponsor ID
- QW2013
- Keywords
- medical abortion, postabortion contraception, LARC, Nexplanon, subdermal contraceptive implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Aug 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.
Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etonorgestrel and mifepristone | Experimental | Drug: Mifepristone, Drug: etonorgestrelQuickstart, insertion of Nexplanon on the day of mifepristone in medical abortion |
| mifepristone | Active comparator | Drug: MifepristoneMifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women opting for medical abortion and post abortion Nexplanon
- no contraindicated to medical abortion or Nexplanon (according to the SMPc) gestational length up to and including 63 days (determined with ultrasonography)
- able and willing to provide informed consent
Key exclusion criteria (5 listed)
- unwilling to participate,
- unable to communicate in Swedish and English and
- minors (i.e. women < 18 years of age),
- contraindications to Nexplanon®
- women with pathological pregnancies
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 |
|---|---|---|
| MifepristoneDay one of medical abortion | Drug | Etonorgestrel and mifepristone, mifepristone |
| etonorgestrelAlso: Nexplanon, Contraceptive implant | Drug | Etonorgestrel and mifepristone |
Primary outcome
Complete abortions without surgical intervention
Time frame: at 3 weeks follow up
Efficacy of the medical abortion treatment
4 secondary outcomes
Unplanned pregnancy
Time frame: during one year FU
Number of women with complications
Time frame: evaluated at the 3weeks FU
Rate of implant insertion
Time frame: up to 1year FU
Bleeding
Time frame: Evaluated at 1 year FU
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 25 Feb 2016.
- Derived from this study: PubMed 27664217Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, Aronsson A, Lindh I, Benson L, Gemzell-Danielsson K. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial. Hum Reprod. 2016 Nov;31(11):2484-2490. doi: 10.1093/humrep/dew238. Epub 2016 Sep 22.
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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.
Kristina Gemzell-Danielsson, MD, PhD principal investigator
Karolinska Institutet
7 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 Mifepristone and etonorgestrel in people with Early Pregnancy Termination and Medical Abortion, run by Karolinska Institutet at 7 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 3 inclusion and 5 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, United Kingdom. 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?
Complete abortions without surgical intervention (time frame: at 3 weeks follow up). 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 NCT01920022, 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 25 Feb 2016.