Pregnancy, UnplannedLIFENCT01539720
Levonorgestrel Intrauterine System For Emergency Contraception
A study testing Ulipristal acetate and levonorgestrel IUS in people with Pregnancy, Unplanned and Pregnancy; Accident, run by Planned Parenthood of the St. Louis Region and Southwest Missouri at 3 sites in United States.
Trial summary
The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Unplanned, Pregnancy; Accident
- What is being tested?
- Ulipristal acetate and levonorgestrel IUS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2012to 30 Nov 2018
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women age 14-45
- Under-protected intercourse within the last five days (120 hours)
- Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
- Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
- Ability and willingness to be contacted by phone for 6 and 12 month follow-up
Who cannot join
- Positive pregnancy test
- Non-English speaking
- Contraindication to intrauterine contraception or oral EC
- Inability or unwillingness to comply with follow-up
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta Women's Center
Atlanta, Georgia, 30342
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63108
About this study
Official title: Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial
The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse.
While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
Read the detailed description
Unintended pregnancy rates in the United States are among the highest of developed nations. These high rates can largely be attributed to incorrect or under contraception of women. One focus of decreasing unintended pregnancy and abortion rates has centered on expanding access to and use of long acting reversible contraceptive (LARC) methods which include intrauterine devices (IUDs) and subdermal implants. Emergency contraception, or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. The most common methods of emergency contraception used in the United States are the oral levonorgestrel regimen and oral ulipristal acetate (Ella) regimen which reduce pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device (Copper IUD). The IUD has the added benefit of providing extended contraceptive use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated with heavier and more crampy menses however, likely dissuading women from use. Among all IUD users, the levonorgestrel intrauterine system (LNG-IUS) has gained popularity over the Cu-T380, perhaps because it offers the potential to improve menstrual related symptoms. There is no data however on the efficacy of the LNG-IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral emergency contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following method allocation for pregnancy. Lastly, participants will be asked to complete a telephone surveys at 6 and 12 months following method allocation assessing their use of a consistent contraceptive method, their satisfaction with their contraceptive method, any use of emergency contraception since their enrollment in the study, and lastly any unintended pregnancies experienced since enrollment in the study. If we could show that the LNG-IUS is as effective as the most commonly prescribed method of emergency contraception, we would be introducing another opportunity for LARC initiation and subsequently impacting unintended pregnancy and abortion rates.
- Conditions
- Pregnancy, Unplanned, Pregnancy; Accident
- Being tested
- Ulipristal acetate, levonorgestrel IUS
- Keywords
- emergency contraception, Ella, Mirena IUD, post-coital contraception, Liletta IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal acetateDrug
Also called Ella
30 mg tablet
levonorgestrel IUSDevice
Also called Mirena IUD, Liletta
Levonorgestrel IUS, 52mg placed intrauterine
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel Intrauterine System | Experimental | Participants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. Receives: Device: levonorgestrel IUS |
| Ulipristal acetate | Active comparator | Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. Receives: Drug: Ulipristal acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pregnancy Following Emergency Contraception
Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.
Measured: 5 weeks post-randomization
Secondary outcomes (2)
Number of Participants Using Any LARC Method at 6 Months Post Randomization
The number of participants who reported using any type of long acting reversible contraception (LARC) use at 6 months following method allocation will be evaluated, whether or not it was their allocated LNG-IUS.
Measured: 6 months post randomization
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS
Continuation and satisfaction among participants in the LNG-IUS arm who reported still using their LNG-IUS at 6 month post randomization.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startDec 2012
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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.
- Other trials for Pregnancy, UnplannedStudies 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
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of the St. Louis Region and Southwest Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- William and Flora Hewlett Foundation, University of Colorado, Denver, Planned Parenthood Federation of America, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Colleen McNicholas, DO, MCSI, Principal investigator, Planned Parenthood of the St. Louis Region and Southwest Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539720
- Sponsor's protocol ID
- 201201007
- Acronym
- LIFE
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2012
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01539720
- Acronym / sponsor ID
- LIFE / 201201007
- Conditions
- Pregnancy, Unplanned, Pregnancy; Accident
- Keywords
- emergency contraception, Ella, Mirena IUD, post-coital contraception, Liletta IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Planned Parenthood of the St. Louis Region and Southwest MissouriUniversity, hospital or other
- Collaborators
- William and Flora Hewlett Foundation, University of Colorado, Denver, Planned Parenthood Federation of America, University of Rochester
- Study start
- Dec 2012
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse.
While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
Detailed description
Unintended pregnancy rates in the United States are among the highest of developed nations. These high rates can largely be attributed to incorrect or under contraception of women. One focus of decreasing unintended pregnancy and abortion rates has centered on expanding access to and use of long acting reversible contraceptive (LARC) methods which include intrauterine devices (IUDs) and subdermal implants. Emergency contraception, or post-coital contraception, offers significant reductions in the chance of pregnancy following an act of unprotected or under-protected vaginal intercourse. The most common methods of emergency contraception used in the United States are the oral levonorgestrel regimen and oral ulipristal acetate (Ella) regimen which reduce pregnancy risk by up to 89%. More effective, but rarely used, is the Cu T-380 intrauterine device (Copper IUD). The IUD has the added benefit of providing extended contraceptive use beyond the single episode of unprotected intercourse. The Cu-T380 has been associated with heavier and more crampy menses however, likely dissuading women from use. Among all IUD users, the levonorgestrel intrauterine system (LNG-IUS) has gained popularity over the Cu-T380, perhaps because it offers the potential to improve menstrual related symptoms. There is no data however on the efficacy of the LNG-IUS as a form of emergency contraception. The purpose of this study is to evaluate the efficacy of the LNG-IUS as a method of emergency contraception. Participants will be randomized to receive either the most common method, oral emergency contraception, or the LNG-IUS. Participants will then be evaluated 5-6 weeks following method allocation for pregnancy. Lastly, participants will be asked to complete a telephone surveys at 6 and 12 months following method allocation assessing their use of a consistent contraceptive method, their satisfaction with their contraceptive method, any use of emergency contraception since their enrollment in the study, and lastly any unintended pregnancies experienced since enrollment in the study. If we could show that the LNG-IUS is as effective as the most commonly prescribed method of emergency contraception, we would be introducing another opportunity for LARC initiation and subsequently impacting unintended pregnancy and abortion rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel Intrauterine System | Experimental | Device: levonorgestrel IUSParticipants randomized to the levonorgestrel IUS will undergo placement at the time of randomization. They will follow-up with a self-administered urine pregnancy test 5-6 weeks following. |
| Ulipristal acetate | Active comparator | Drug: Ulipristal acetateWomen in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Women age 14-45
- Under-protected intercourse within the last five days (120 hours)
- Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
- Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
- Ability and willingness to be contacted by phone for 6 and 12 month follow-up
Key exclusion criteria (4 listed)
- Positive pregnancy test
- Non-English speaking
- Contraindication to intrauterine contraception or oral EC
- Inability or unwillingness to comply with follow-up
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 |
|---|---|---|
| Ulipristal acetateAlso: Ella30 mg tablet | Drug | Ulipristal acetate |
| levonorgestrel IUSAlso: Mirena IUD, LilettaLevonorgestrel IUS, 52mg placed intrauterine | Device | Levonorgestrel Intrauterine System |
Primary outcome
Number of Participants With Pregnancy Following Emergency Contraception
Time frame: 5 weeks post-randomization
Observed pregnancies at 5 weeks and at 6 months in the LNG-IUD group will be compared to those in the oral UPA group.
2 secondary outcomes
Number of Participants Using Any LARC Method at 6 Months Post Randomization
Time frame: 6 months post randomization
Number of Participants Reporting Continuation and Satisfaction With Their Study Allocated LNG-IUS
Time frame: 6 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pregnancy, Unplanned
Active, not recruiting
Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
Pregnancy, Unplanned, Contraceptive Behavior
Recruiting
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Neurogenic Bladder, Urinary Retention
Recruiting
Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
Pregnancy
Active, not recruiting
Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1
Pregnancy
RecruitingObservational study
Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery
Post Traumatic Stress Disorder, Post Partum Depression
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.
Colleen McNicholas, DO, MCSI principal investigator
Planned Parenthood of the St. Louis Region and Southwest Missouri
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulipristal acetate and levonorgestrel IUS in people with Pregnancy, Unplanned and Pregnancy; Accident, run by Planned Parenthood of the St. Louis Region and Southwest Missouri at 3 sites 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 4 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 20 Feb 2024). 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 With Pregnancy Following Emergency Contraception (time frame: 5 weeks post-randomization). 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 20 Feb 2024.