PregnancyNCT00669396
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
A study testing Copper T380 IUD and levonorgestrel in people with Pregnancy, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Copper T380 IUD and levonorgestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2009
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
- Patients selecting the IUD need to identify themselves as desiring long-term contraception.
Who cannot join
- Current pregnancy,
- Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
- Intracavitary of symptomatic uterine fibroids, and 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 unknown etiology
- Ovarian, cervical or endometrial cancer,
- Small uterine cavity
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, 84119
About this study
Official title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.
Read the detailed description
This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.
Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
- Conditions
- Pregnancy
- Being tested
- Copper T380 IUD, 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 T380 IUD
levonorgestrelDrug
Also called Plan B
1.5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IUD Receives: Drug: Copper T380 IUD |
| 2 | Active comparator | Oral levonorgestrel Receives: Drug: levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
Measured: 6 months
Secondary outcomes (3)
Pregnancy
positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Measured: 6 months
Infection
diagnosis and treatment for pelvic inflammatory disease
Measured: 6 months
IUD Expulsion, Removal, or Perforation
patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionMay 2009
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 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/MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669396
- Sponsor's protocol ID
- 23111
- Other IDs
- IUDvsPlanBforEC
- Status last verified
- Dec 2014
- First submitted
- 25 Apr 2008
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
- ClinicalTrials.gov ID
- NCT00669396
- Acronym / sponsor ID
- 23111
- Conditions
- Pregnancy
- Keywords
- contraception, emergency contraception, pregnancy prevention after unprotected intercourse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Posted 6 Aug 2009
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) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.
Detailed description
This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.
Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Copper T380 IUDIUD |
| 2 | Active comparator | Drug: levonorgestrelOral levonorgestrel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone.
- Patients selecting the IUD need to identify themselves as desiring long-term contraception.
Key exclusion criteria (10 listed)
- Current pregnancy,
- Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days,
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy to levonorgestrel (for patients selecting Plan B)
- Intracavitary of symptomatic uterine fibroids, and 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 T380 IUD | Drug | 1 |
| levonorgestrelAlso: Plan B1.5 mg | Drug | 2 |
Primary outcome
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Time frame: 6 months
Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
3 secondary outcomes
Pregnancy
Time frame: 6 months
Infection
Time frame: 6 months
IUD Expulsion, Removal, or Perforation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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/MPH 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?
A study testing Copper T380 IUD and levonorgestrel in people with Pregnancy, 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 2 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 22 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2009). 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?
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception (time frame: 6 months). 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 22 Dec 2014.