ContraceptionPhase 4NCT02175030
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
A Phase 4 study testing Copper IUD and Levonorgestrel IUD in people with Contraception, run by University of Utah at 6 sites in United States.
Trial summary
This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Copper IUD and Levonorgestrel IUD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2016to Dec 2020
- Phase
- Phase 4
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females between 18-35 years old
- In need of EC (had unprotected intercourse within 120 hours - 5 days)
- Desire to prevent pregnancy for 1 year
- Fluent in English and/or Spanish
- Have a regular menstrual cycle (21-35 days)
- Know their last menstrual period (+/-3 days)
Show all 9Show fewer
- Be willing to comply with the study requirements
- Desire to initiate an IUD
- Negative urine pregnancy test
Who cannot join
- Current pregnancy
- Breastfeeding
- Intrauterine infection within the past three months
- Sterilization
- Already have an IUD or contraception implant (Nexplanon) in place
- Vaginal bleeding of unknown etiology
Show all 10Show fewer
- Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)
- Known abnormalities of the uterus that distort the uterine cavity
- Allergy to copper
- Use of oral Emergency Contraception in the preceeding 5 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Planned Parenthood Association of Utah
Logan, Utah, 84321
Planned Parenthood Association of Utah
Ogden, Utah, 84403
Planned Parenthood Association of Utah
Orem, Utah, 84057
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
Planned Parenthood Association of Utah
South Jordan, Utah, 84095
Planned Parenthood Association of Utah
West Valley City, Utah, 84119
About this study
Official title: RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.
Read the detailed description
Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).
Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.
- Conditions
- Contraception
- Being tested
- Copper IUD, Levonorgestrel IUD
- Keywords
- Emergency contraception, Levonorgestrel IUD, Copper IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper IUDDrug
Also called Paragard IUD
Randomization to copper/Paragard IUD for emergency contraception
Levonorgestrel IUDDrug
Also called Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD
Randomization to Levonorgestrel/Mirena IUD for emergency contraception
| Study group | Role | What they receive |
|---|---|---|
| Copper T380 IUD | Active comparator | Randomized to copper T380 IUD for EC (emergency contraception) Receives: Drug: Copper IUD |
| LNG20 IUD | Active comparator | Randomized to LNG20 IUD for EC (emergency contraception) Receives: Drug: Levonorgestrel IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting a Pregnancy
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD.
Measured: 1 month after enrollment
Secondary outcomes (1)
Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startAug 2016
- Primary completionFeb 2020
- Study completionDec 2020
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 (4)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Turok, University of Utah
- Investigators
- David Turok, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175030
- Sponsor's protocol ID
- 73554
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2014
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kaiser JE, Turok DK, Gero A, Gawron LM, Simmons RG, Sanders JN. One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial. Am J Obstet Gynecol. 2023 Apr;228(4):438.e1-438.e10. doi: 10.1016/j.ajog.2022.11.1296. Epub 2022 Nov 23.
PubMed 36427600BakenRa A, Gero A, Sanders J, Simmons R, Fay K, Turok DK. Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception. Obstet Gynecol. 2021 Jul 1;138(1):79-84. doi: 10.1097/AOG.0000000000004433.
PubMed 34259467Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.
PubMed 33706343Turok DK, Gero A, Simmons RG, Kaiser JE, Stoddard GJ, Sexsmith CD, Gawron LM, Sanders JN. Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception. N Engl J Med. 2021 Jan 28;384(4):335-344. doi: 10.1056/NEJMoa2022141.
PubMed 33503342
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception
- ClinicalTrials.gov ID
- NCT02175030
- Acronym / sponsor ID
- 73554
- Conditions
- Contraception
- Keywords
- Emergency contraception, Levonorgestrel IUD, Copper IUD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the most effective method of emergency contraception vs. the levonorgestrel IUD, the most preferred IUD which has never been tested as an emergency contraceptive. This research has the potential to increase use of highly effective contraception in a high-risk population and lower the persistently elevated rate of U.S. unintended pregnancy.
Detailed description
Unintended pregnancy has multiple adverse effects on both maternal and child health. The United States continues to have one of the highest rates of unintended pregnancy among developed countries. To combat this problem, we are studying initiation of the highly effective intrauterine device (IUD) for women presenting for emergency contraception (EC). This is an ideal population to initiate highly effective reversible contraception (HERC) as they are at high risk of unintended pregnancy and are acting to reduce that risk. We have recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).
Not only is the copper IUD the most effective method of EC, it is considered a top tier anticipatory contraception method and its ability to prevent pregnancy is on par with tubal sterilization (less than 1% in the first year with lower failure rates in subsequent years). However, women selecting intrauterine contraception have shown a strong preference for the LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some non-contraceptive effects that many women see as benefits such as the reduction or elimination of menstrual bleeding and menstrual related discomfort. Of currently available reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and continuation. However, its effectiveness as an emergency contraceptive remains unknown. A randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC. Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve options for women seeking EC and who desire a highly effective method of contraception.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper T380 IUD | Active comparator | Drug: Copper IUDRandomized to copper T380 IUD for EC (emergency contraception) |
| LNG20 IUD | Active comparator | Drug: Levonorgestrel IUDRandomized to LNG20 IUD for EC (emergency contraception) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Females between 18-35 years old
- In need of EC (had unprotected intercourse within 120 hours - 5 days)
- Desire to prevent pregnancy for 1 year
- Fluent in English and/or Spanish
- Have a regular menstrual cycle (21-35 days)
Key exclusion criteria (10 listed)
- Current pregnancy
- Breastfeeding
- Intrauterine infection within the past three months
- Sterilization
- Already have an IUD or contraception implant (Nexplanon) in place
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 |
|---|---|---|
| Copper IUDAlso: Paragard IUDRandomization to copper/Paragard IUD for emergency contraception | Drug | Copper T380 IUD |
| Levonorgestrel IUDAlso: Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUDRandomization to Levonorgestrel/Mirena IUD for emergency contraception | Drug | LNG20 IUD |
Primary outcome
Percentage of Participants Reporting a Pregnancy
Time frame: 1 month after enrollment
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD.
1 secondary outcome
Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
Time frame: 1 year after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36427600Kaiser JE, Turok DK, Gero A, Gawron LM, Simmons RG, Sanders JN. One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial. Am J Obstet Gynecol. 2023 Apr;228(4):438.e1-438.e10. doi: 10.1016/j.ajog.2022.11.1296. Epub 2022 Nov 23.
- Derived from this study: PubMed 34259467BakenRa A, Gero A, Sanders J, Simmons R, Fay K, Turok DK. Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception. Obstet Gynecol. 2021 Jul 1;138(1):79-84. doi: 10.1097/AOG.0000000000004433.
- Derived from this study: PubMed 33706343Boraas CM, Sanders JN, Schwarz EB, Thompson I, Turok DK. Risk of Pregnancy With Levonorgestrel-Releasing Intrauterine System Placement 6-14 Days After Unprotected Sexual Intercourse. Obstet Gynecol. 2021 Apr 1;137(4):623-625. doi: 10.1097/AOG.0000000000004118.
- Derived from this study: PubMed 33503342Turok DK, Gero A, Simmons RG, Kaiser JE, Stoddard GJ, Sexsmith CD, Gawron LM, Sanders JN. Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception. N Engl J Med. 2021 Jan 28;384(4):335-344. doi: 10.1056/NEJMoa2022141.
- Individual participant dataSharing planned: No
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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.
David Turok, MD principal investigator
University of Utah
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Copper IUD and Levonorgestrel IUD in people with Contraception, run by University of Utah at 6 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 9 inclusion and 10 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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Yes. Results are posted in the registry (first posted 29 Jun 2022). 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?
Percentage of Participants Reporting a Pregnancy (time frame: 1 month after enrollment). 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 NCT02175030, which also lists 4 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 29 Jun 2022.