Emergency ContraceptionCOLIECNCT01963962
Study of the Copper IUD or Oral Levonorgestrel and the Levonorgestrel IUD for Women Seeking Emergency Contraception
An observational study of Emergency Contraception, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- Copper IUD and Levonorgestrel IUD
- Type of treatment
- Pill or oral medicine
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2016
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT
Who may be able to join
- 2. In need of EC (had unprotected intercourse within 120 hours - 5 days)
- 3. Desire to prevent pregnancy for 1 year
- 4. Fluent in English and/or Spanish
- 5. Have a regular menstrual cycle (24-35 days)
- 6. Know their last menstrual period (+/-3 days)
- 7. Be willing to comply with the study requirements
- 8. Participants current preferred phone number must be functioning at the time of study entry and will be tested prior to enrollment
- -
Who cannot join
- 1. Current pregnancy
- 2. Breastfeeding
- 3. Intrauterine infection within the past 3 months
- 4. Sterilization
- 5. Already have an IUD or contraceptive implant (Implanon) in place
- 6. Vaginal bleeding of unknown etiology
Show all 10Show fewer
- 7. Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry)
- 8. Allergy to LNG (for LNG IUD patients)
- 9. Allergy to copper or Wilson's disease (for Copper IUD patients)
- 10. Known abnormalities of the uterus that distort the uterine cavity
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
About this study
Official title: A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.
Read the detailed description
Widely available oral levonorgestrel (LNG) for emergency contraception (EC) has not reduced unplanned pregnancy rates. However, our study of the copper T380 IUD vs. oral LNG for EC showed lower pregnancy rates 12 months after presenting for EC in the copper IUD group. Because there is a strong preference for the LNG IUD among women offered the IUD, the objective of this research project is to initiate investigation into, and use of the LNG IUD in the setting of EC. Our experienced team of EC researchers proposes the following aims to provide needed information in this understudied area:
Aim 1: To assess uptake of the LNG IUD vs. the copper IUD among women presenting for EC exposed to standardized counseling.
Aim 2: Gather baseline data on one-year continuation and pregnancy rates from women initiating the LNG IUD vs. the copper T380 IUD when presenting for EC.
Aim 3: Assess willingness of women presenting for EC to participate in a future randomized controlled trial comparing the LNG IUD vs. the copper T380 IUD for EC.
The study aims will be accomplished with a prospective observational trial of women who choose either method of EC. The investigative team will recruit 180 women who present for EC at two participating family planning clinics and follow study participants for 12 months. This project will compare continuation and pregnancy rates between LNG and copper IUD users in the year following presentation for EC. This proposal is another aspect in our growing research program offering highly effective contraception at the time of EC presentation. Results of this project will direct future study in this area aimed at reducing population unplanned pregnancy rates among EC users with the potential to inform a future RCT of the LNG vs. copper IUD for EC.
- Conditions
- Emergency Contraception
- Being tested
- Copper IUD, Levonorgestrel IUD
- Keywords
- Emergency contraception, Levonorgestrel IUD, Copper IUD, Oral Levonorgestrel
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
Levonorgestrel IUDDrug
Also called Mirena IUD
| Study group | Role | What they receive |
|---|---|---|
| Copper IUD | Women selecting the copper IUD for emergency contraception and to use for contraception after Receives: Drug: Copper IUD | |
| Levonorgestrel IUD | Women who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time. Receives: Drug: Levonorgestrel IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates in first month after IUD insertion
Participants will have a urine pregnancy test at the clinic. They will also be given a home urine pregnancy test to check if they are not able to return to clinic and will give results by phone or electronic communication.
Measured: 4 weeks
Secondary outcomes (1)
1 Year IUD continuation rates
IUD continuation rates will be compared between those who selected the copper IUD and thos who selected the levonorgestrel IUD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionFeb 2016
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 Emergency 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 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
- NCT01963962
- Sponsor's protocol ID
- 50483
- Acronym
- COLIEC
- Status last verified
- Aug 2016
- First submitted
- 11 Oct 2013
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boraas 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, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016 Jun;93(6):526-32. doi: 10.1016/j.contraception.2016.01.009. Epub 2016 Mar 2.
PubMed 26944863
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
- ClinicalTrials.gov ID
- NCT01963962
- Acronym / sponsor ID
- COLIEC / 50483
- Conditions
- Emergency Contraception
- Keywords
- Emergency contraception, Levonorgestrel IUD, Copper IUD, Oral Levonorgestrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Oct 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.
The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.
Detailed description
Widely available oral levonorgestrel (LNG) for emergency contraception (EC) has not reduced unplanned pregnancy rates. However, our study of the copper T380 IUD vs. oral LNG for EC showed lower pregnancy rates 12 months after presenting for EC in the copper IUD group. Because there is a strong preference for the LNG IUD among women offered the IUD, the objective of this research project is to initiate investigation into, and use of the LNG IUD in the setting of EC. Our experienced team of EC researchers proposes the following aims to provide needed information in this understudied area:
Aim 1: To assess uptake of the LNG IUD vs. the copper IUD among women presenting for EC exposed to standardized counseling.
Aim 2: Gather baseline data on one-year continuation and pregnancy rates from women initiating the LNG IUD vs. the copper T380 IUD when presenting for EC.
Aim 3: Assess willingness of women presenting for EC to participate in a future randomized controlled trial comparing the LNG IUD vs. the copper T380 IUD for EC.
The study aims will be accomplished with a prospective observational trial of women who choose either method of EC. The investigative team will recruit 180 women who present for EC at two participating family planning clinics and follow study participants for 12 months. This project will compare continuation and pregnancy rates between LNG and copper IUD users in the year following presentation for EC. This proposal is another aspect in our growing research program offering highly effective contraception at the time of EC presentation. Results of this project will direct future study in this area aimed at reducing population unplanned pregnancy rates among EC users with the potential to inform a future RCT of the LNG vs. copper IUD for EC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper IUD | – | Drug: Copper IUDWomen selecting the copper IUD for emergency contraception and to use for contraception after |
| Levonorgestrel IUD | – | Drug: Levonorgestrel IUDWomen who select oral levonorgestrel for emergency contraception and begin the levonorgestrel IUD for ongoing contraception at the same time. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women presenting for emergency contraception to family planning clinics in Salt Lake City, UT
Key inclusion criteria (8 listed)
- 2. In need of EC (had unprotected intercourse within 120 hours - 5 days)
- 3. Desire to prevent pregnancy for 1 year
- 4. Fluent in English and/or Spanish
- 5. Have a regular menstrual cycle (24-35 days)
- 6. Know their last menstrual period (+/-3 days)
Key exclusion criteria (10 listed)
- 1. Current pregnancy
- 2. Breastfeeding
- 3. Intrauterine infection within the past 3 months
- 4. Sterilization
- 5. Already have an IUD or contraceptive implant (Implanon) 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 IUD | Drug | Copper IUD |
| Levonorgestrel IUDAlso: Mirena IUD | Drug | Levonorgestrel IUD |
Primary outcome
Pregnancy rates in first month after IUD insertion
Time frame: 4 weeks
Participants will have a urine pregnancy test at the clinic. They will also be given a home urine pregnancy test to check if they are not able to return to clinic and will give results by phone or electronic communication.
1 secondary outcome
1 Year IUD continuation rates
Time frame: 1 year
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 8 Aug 2016.
- 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 26944863Turok DK, Sanders JN, Thompson IS, Royer PA, Eggebroten J, Gawron LM. Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study. Contraception. 2016 Jun;93(6):526-32. doi: 10.1016/j.contraception.2016.01.009. Epub 2016 Mar 2.
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.
David Turok, MD principal investigator
University of Utah
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, run by University of Utah at 1 site 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 8 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 8 Aug 2016. 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 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?
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?
Pregnancy rates in first month after IUD insertion (time frame: 4 weeks). 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 NCT01963962, 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 8 Aug 2016.