Emergency ContraceptionNCT02078414
Continued Use of Effective Contraception After Use of Emergency Contraception
An observational study of Emergency Contraception and Contraception, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Emergency Contraception, Contraception, Reproductive Health
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to May 2015
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women without contraception or with a failed contraceptive method seeking emergency contraception
Who may be able to join
- women over 18 years
- eligible for all emergency contraception
Who cannot join
- previous conisation
- known stenosis of the cervix
- signs of ongoing genital infection
- known uterine anomaly
- Known bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).
- Conditions
- Emergency Contraception, Contraception, Reproductive Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal acetate | Women choosing EllaOne as emergency contraception | |
| Copper IUD | Women choosing copper IUD as emergency contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of an effective contraceptive method
Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method
Measured: 6 months after emergency contraceptive use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency ContraceptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Kopp Kallner, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078414
- Sponsor's protocol ID
- RFSU1
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2014
- Last updated
- 29 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Use of Effective Contraception After Use of Emergency Contraception
- ClinicalTrials.gov ID
- NCT02078414
- Acronym / sponsor ID
- RFSU1
- Conditions
- Emergency Contraception, Contraception, Reproductive Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Mar 2014 (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 using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulipristal acetate | – | –Women choosing EllaOne as emergency contraception |
| Copper IUD | – | –Women choosing copper IUD as emergency contraception |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women without contraception or with a failed contraceptive method seeking emergency contraception
Key inclusion criteria (2 listed)
- women over 18 years
- eligible for all emergency contraception
Key exclusion criteria (5 listed)
- previous conisation
- known stenosis of the cervix
- signs of ongoing genital infection
- known uterine anomaly
- Known bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Use of an effective contraceptive method
Time frame: 6 months after emergency contraceptive use
Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method
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 29 Nov 2023.
Related trials for Emergency Contraception
Recruiting
The Influence of Plan B® on Cardiovascular Health.
Female, Premenopausal
RecruitingPhase 4
Etonogestrel Implant as Emergency Contraception
Contraception
RecruitingPhase 4
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Contraceptive Usage
RecruitingPhase 4
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
Emergency Contraception
RecruitingPhase 3
Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
Contraception
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Contraception and Contraception, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 29 Nov 2023. 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 Sweden. 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?
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?
Use of an effective contraceptive method (time frame: 6 months after emergency contraceptive use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.