PregnancyIUD ECNCT00966771
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
An observational study of Pregnancy, run by University of Utah at 2 sites in United States.
Trial summary
The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Copper T380 IUD and Oral levonorgestrel
- Type of treatment
- Pill or oral medicine
- How many people
- 548 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Aug 2011
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women presenting to family planning clinics for emergency contraception
Who may be able to join
- Women 18-30 years old,
- in need of emergency contraception (had unprotected intercourse within 120 hours),
- willing to give consent for participation in research,
- willing to comply with study requirements, and
- accessible by telephone.
- Participants selecting the IUD need to identify themselves as desiring long-term contraception.
Who cannot join
- Current pregnancy
- Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
- Abnormalities of the uterus that distort the uterine cavity
- Mucopurulent cervicitis
Show all 10Show fewer
- A previously placed IUD that has not been removed
- Genital bleeding of an unknown etiology
- Ovarian, cervical, or endometrial cancer
- Small uterine cavity (< 6cm)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood Association of Utah Salt Lake City Clinic
Salt Lake City, Utah, 84102-3430
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, 84119-4715
About this study
Official title: Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.
Read the detailed description
All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.
Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
- Conditions
- Pregnancy
- Being tested
- Copper T380 IUD, Oral levonorgestrel
- Keywords
- contraception, emergency contraception, pregnancy prevention after unprotected intercourse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper T380 IUDDrug
Also called Paragard IUD
copper T 380 IUD
Oral levonorgestrelDrug
Also called Plan B
1.5 mg
| Study group | Role | What they receive |
|---|---|---|
| IUD | Women presenting for emergency contraception who select the copper IUD Receives: Drug: Copper T380 IUD | |
| Oral levonorgestrel | Women presenting for emergency contraception who select oral levonorgestrel Receives: Drug: Oral levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned pregnancy
Measured: within 12 months of presenting for EC
Secondary outcomes (2)
Use of an effective method of contraception in the year following use of emergency contraception.
Measured: 12 months
IUD expulsion, removal or perforation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionAug 2011
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 PregnancyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Society of Family Planning
- 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
- NCT00966771
- Sponsor's protocol ID
- 30937
- Other IDs
- 1R21HD063028-01A1
- Acronym
- IUD EC
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 2009
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Royer PA, Turok DK, Sanders JN, Saltzman HM. Choice of Emergency Contraceptive and Decision Making Regarding Subsequent Unintended Pregnancy. J Womens Health (Larchmt). 2016 Oct;25(10):1038-1043. doi: 10.1089/jwh.2015.5625. Epub 2016 Mar 31.
PubMed 27032057Torres LN, Turok DK, Sanders JN, Jacobson JC, Dermish AI, Ward K. We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months. Contraception. 2014 Dec;90(6):575-80. doi: 10.1016/j.contraception.2014.07.013. Epub 2014 Aug 1.
PubMed 25242443
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
- ClinicalTrials.gov ID
- NCT00966771
- Acronym / sponsor ID
- IUD EC / 30937
- Conditions
- Pregnancy
- Keywords
- contraception, emergency contraception, pregnancy prevention after unprotected intercourse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Society of Family Planning
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Aug 2009 (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 if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.
Detailed description
All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.
Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUD | – | Drug: Copper T380 IUDWomen presenting for emergency contraception who select the copper IUD |
| Oral levonorgestrel | – | Drug: Oral levonorgestrelWomen presenting for emergency contraception who select oral levonorgestrel |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women presenting to family planning clinics for emergency contraception
Key inclusion criteria (6 listed)
- Women 18-30 years old,
- in need of emergency contraception (had unprotected intercourse within 120 hours),
- willing to give consent for participation in research,
- willing to comply with study requirements, and
- accessible by telephone.
Key exclusion criteria (10 listed)
- Current pregnancy
- Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
- Abnormalities of the uterus that distort the uterine cavity
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 T380 IUDAlso: Paragard IUDcopper T 380 IUD | Drug | IUD |
| Oral levonorgestrelAlso: Plan B1.5 mg | Drug | Oral levonorgestrel |
Primary outcome
Unplanned pregnancy
Time frame: within 12 months of presenting for EC
2 secondary outcomes
Use of an effective method of contraception in the year following use of emergency contraception.
Time frame: 12 months
IUD expulsion, removal or perforation
Time frame: 12 months
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 6 Feb 2017.
- Derived from this study: PubMed 27032057Royer PA, Turok DK, Sanders JN, Saltzman HM. Choice of Emergency Contraceptive and Decision Making Regarding Subsequent Unintended Pregnancy. J Womens Health (Larchmt). 2016 Oct;25(10):1038-1043. doi: 10.1089/jwh.2015.5625. Epub 2016 Mar 31.
- Derived from this study: PubMed 25242443Torres LN, Turok DK, Sanders JN, Jacobson JC, Dermish AI, Ward K. We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months. Contraception. 2014 Dec;90(6):575-80. doi: 10.1016/j.contraception.2014.07.013. Epub 2014 Aug 1.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Utah at 2 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 6 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Unplanned pregnancy (time frame: within 12 months of presenting for EC). 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 NCT00966771, 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 6 Feb 2017.